Hologic receives FDA approval of prone biopsy system

Hologic announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of the Affirm prone biopsy system, the first dedicated prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies.

With a larger field of view than existing dedicated prone biopsy systems, the new Affirm prone biopsy system allows radiologists to better target lesions found during 3D MAMMOGRAPHY exams, as well as other screening modalities. Furthermore, this new product features a streamlined workflow with increased automation designed to make using the system fast and easy. With the patient lying prone, the biopsy system provides true 360-degree access to lesions using a fully integrated C-Arm. Approach angles can be varied with minimal movement on the patient's part, as the patient is supported stably throughout the procedure. In addition to these important benefits for clinicians, the system's design aims to increase patient satisfaction through faster procedure times than Hologic's market leading MultiCare Platinum system, and comfortable prone positioning that eliminates a direct view of the biopsy needle.

The system is CE marked, and Hologic has begun installing Affirm prone systems at leading imaging sites in Europe. The Affirm prone biopsy system expands Hologic's breast biopsy portfolio, complementing the Company's Genius 3D MAMMOGRAPHY exam and Affirm upright biopsy system. This portfolio equips hospitals and imaging centers with the options necessary to provide minimally invasive breast biopsies for their patients.

For additional information on the Affirm prone biopsy system, please visit www.affirmpronebiopsy.com.

Medtronic Launches New Endoscopic Ablation Catheter for Barrett's Esophagus

Medtronic announced the launch of the new BarrxTM 360 Express radiofrequency ablation (RFA) balloon catheter, which can help in the treatment of Barrett's esophagus.

"In reducing the progression of dysplastic Barrett's esophagus to esophageal cancer, the launch of the Barrx 360 Express RFA balloon catheter underscores our commitment to patients," said Vafa Jamali, president, Early Technologies business in the Medtronic Minimally Invasive Therapies Group. "We believe patients and physicians will benefit from the easier-to-use technology of the Barrx 360 Express catheter, which provides a more precise delivery of RF energy to the targeted area."

The company is currently launching the Barrx 360 Express RFA balloon catheter in the United States. The catheter is also expected to be available in the EU, Australia and New Zealand in 2016.

More information can be found from Medtronic webiste following this link.

Boston Scientific Announces CE Mark For MRI Labeling of S-ICD Systems

Boston Scientific has received CE Mark approval for the new EMBLEM MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.

The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.

In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

In the U.S., the EMBLEM MRI S-ICD System is not available for sale.

Product details can be found from Boston Scientific website by clicking here.

Abbott to Acquire St. Jude Medical

Abbott and St. Jude Medical, Inc. announced on 28 April 2016 a definitive agreement for Abbott to acquire St. Jude Medical, creating a premier medical device leader with top positions in high-growth cardiovascular markets, including atrial fibrillation, structural heart and heart failure as well as a leading position in the high-growth neuromodulation market. Under the agreement, St. Jude Medical shareholders will receive $46.75 in cash and 0.8708 shares of Abbott common stock, representing total consideration of approximately $85 per share. At an Abbott stock price of $43.93(2), this represents a total transaction equity value of $25 billion. The combined company will have an industry-leading pipeline expected to deliver a steady stream of new medical device products across cardiovascular, diabetes, vision and neuromodulation patient care.

St. Jude Medical's strong positions in heart failure devices, atrial fibrillation and cardiac rhythm management complement Abbott's leading positions in coronary intervention and transcatheter mitral repair. Together, the company will compete in nearly every area of the cardiovascular market and hold the No. 1 or 2 positions across large and high-growth cardiovascular device markets. This best-in-class combined portfolio will have the depth, breadth and innovation to help patients restore their health, reduce costs for payors and deliver greater value to customers.

A press release and the financial impact of this transaction can be found here by clicking this link.

Vertebral Motion Analysis System Gets CE Mark

Ortho Kinematics‚ Inc. (OKI), a privately held healthcare diagnostics company focused on spine imaging informatics, announced today it has received CE mark approval for its lead product, Vertebral Motion Analysis “VMA”. CE mark approval is required for the commercialization of the VMA in European markets. Prior to securing CE mark approval, the VMA had regulatory clearance from the US Food and Drug Administration (FDA) to commercialize in the United States. With this additional approval, OKI can begin selling the VMA technology in European Countries.

VMA, or Vertebral Motion Analysis, is a diagnostic test for the assessment of spinal motion and radiographic instability. Today’s current test for assessing spinal radiographic instability is ordered over 5 million times per year in the US, largely by spine surgeons, because it provides diagnostic data that is necessary for many patients being considered for potential spine surgery. The VMA has been shown in peer-reviewed studies to increase the sensitivity in detecting radiographic instability with no decrease in specificity relative to today’s current standard test. It has also been shown to be more accurate, repeatable, and result in a lower dose of radiation.

OKI intends to begin commercialization efforts later this year in the United Kingdom, then expand from there. To support commercial efforts, OKI will be working closely with local distribution partners in each country.

A press release can be found from OKI website by following this link.

EOS imaging Received CFDA Approval for the EOS System

EOS imaging announced that the Company has received approval from the China Food and Drug Administration (CFDA) to market the EOS system in China, further expanding the Company’s commercial opportunities in the fast growing Asia Pacific market. The EOS system can now be marketed in 51 countries.

The EOS system is in clinical use in several markets in the Asia Pacific region, including Hong Kong, Singapore, Japan, Australia and Vietnam. In addition, an EOS equipment is installed in a Shanghai hospital where it is being used for clinical studies, creating awareness for the EOS technology in China. The CFDA approval will allow the company to develop commercial activity in this major market, which includes more than 1,200 top grade (3A and 3B) hospitals, within an established distribution partnership.

Experience with the EOS system will be shared with Chinese physicians by several French radiologists and orthopedic surgeons during the upcoming Jishuitan Orthopedics Forum in Beijing, April 22-24, 2016. The Forum is a biennial, multi-disciplinary event focused on orthopedics that attracts more than 3,000 attendees from over 1,200 hospitals. This year, the Forum includes special sessions for Chinese-French exchange across multiple areas of orthopedic treatment, including spine, joint articulation, pediatrics and radiology.

Marie Meynadier, CEO of EOS imaging, said, “CFDA approval is an important milestone that opens a large and growing market opportunity for our Company. It is consistent with our strategy to expand adoption of the EOS system in 3 major regions – North America, Europe-Middle East and Asia-Pacific – to diversify our revenue growth and long-term potential. We are excited to begin commercial activities in China with our local partner, where there is already positive awareness and demand for the EOS system.”

For more information, please visit www.eos-imaging.com.

Nokia plans to acquire Withings to accelerate entry into Digital Health

Nokia has announced plans to acquire Withings S.A., a pioneer and leader in the connected health revolution with a family of award-winning digital health products and services to help people all over the world lead healthier, happier and more productive lives. Withings will be part of our Nokia Technologies business.

"We have said consistently that digital health was an area of strategic interest to Nokia, and we are now taking concrete action to tap the opportunity in this large and important market," said Rajeev Suri, president & CEO of Nokia. "With this acquisition, Nokia is strengthening its position in the Internet of Things in a way that leverages the power of our trusted brand, fits with our company purpose of expanding the human possibilities of the connected world, and puts us at the heart of a very large addressable market where we can make a meaningful difference in peoples' lives."

"Withings shares our vision for the future of digital health and their products are smart, well designed and already helping people live healthier lives," said Ramzi Haidamus, president of Nokia Technologies. "Combining their award-winning products and talented people with the world-class expertise and innovation of Nokia Technologies uniquely positions us to lead the next wave of innovation in digital health."

The combination of innovative products from Withings and the Digital Health business will also ensure the ongoing renewal of Nokia Technologies' world class IPR portfolio.

The planned transaction values Withings at EUR 170 million and would be settled in cash and is expected to close in early Q3, 2016 subject to regulatory approvals and customary closing conditions.

A press release ca nbe found from Nokia website.

Richard Wolf launches ENDOCAM Flex HD video solution

Richard Wolf launched a new "ENDOCAM Flex HD" video solution to the market.

The ENDOCAM Flex HD has already been presented to a broadly based professional public at the MEDICA International Trade Fair for Medical Technology in 2015. The compact construction and the universal options for application mean that users can carry out endoscopic treatments flexibly, quickly and simply with the ENDOCAM Flex HD. 

A combination of appealing value for money and a customer-centric service concept also provide attractive reasons to invest in this camera system.

The medical technology manufacturer has collected feedback and opinions at http://endocamflexhd.richard-wolf.com/en.html and summarized them on a OnePage layout. Images and clips complement advantages of the new video solution there. Richard Wolf also provides the option of ordering a Test Set so that users in private practices and in hospitals have an opportunity to find out about the impressive features of the ENDOCAM Flex HD.

More product info can be found from Richard Wolf website.

AtriCure Receives FDA Clearance for New AtriClip Device

AtriCure, Inc. announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System. The new AtriClip PRO2 system has increased functionality which enhances the capability to occlude the LAA during minimally-invasive surgical (MIS) procedures.

The AtriClip PRO2 system features an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. The ambidextrous locking and trigger-style clip closing mechanism allows the operator to maintain focus on the LAA while maneuvering the device. The handle-based active articulation levers allow the operator to steer the end effector without removing the device. The hoopless end effector enhances anatomical visualization, and simplifies removal of the applier after deployment of the clip.

AtriCure was the first company to receive FDA clearance for a device designed specifically for occluding the LAA. Through the previous twelve months ending December 31, 2015, sales of AtriClip products grew at a rate of 45% on a global basis as compared to the prior period in 2014. To date, AtriClip products have been used to treat more than 70,000 patients worldwide.

A press release can be found from AtriCure website.

3M Unveils Intelligent Inhaler

The 3M Intelligent Control Inhaler provides a number of unique features that offer opportunities to improve outcomes by reducing patient variability and errors, and providing data on use to health care providers and payers:

• Controlled inspiration: a combination of breath actuation with innovative technology to control inspiratory flow rate significantly reduces errors in technique, and results in a much higher level of consistency of drug delivery between breaths and between patients.
• Integrated patient instructions: the inhaler’s patient-proof design gives patients confidence to use the inhaler correctly and helps eliminate critical errors in use, as well as minimizing the resources dedicated to training patients in correct inhalation technique.
• Fully integrated device: the dose is registered when the patient correctly inhales medication rather than on actuation of the device, delivering greater accuracy of information for the patient, and cost-savings for health care providers who can avoid unnecessary switches and treatment escalation.
• Capture of inspiration data: the inhaler utilizes a data management platform to record not only device usage, but also inspiration profiles to help monitor disease progression, further supporting informed treatment decisions.

The device will be developed in partnership with a pharmaceutical company, and is expected to be in wide use by the end of the decade.

For more information please visit 3M website by clicking here.

BD Introduces New Low-Temperature Sterilization Containers

BD (Becton, Dickinson and Company) announced a new line of surgical instrument sterilization containers that are validated for the latest low-temperature sterilization processes.

The Genesis™ Low Temperature Rigid Sterilization Container System is validated for newer low-temperature sterilization processes and systems from market-leading sterilizer manufacturers, including the V-PRO® Low Temperature Sterilization Systems from STERIS and STERRAD® Systems from Advanced Sterilization Products (ASP). Low-temperature sterilization is a fast-growing trend in sterile processing and is used for instrumentation that cannot withstand the high-temperature and moisture present in traditional steam sterilization practices.

The new containers have a visually differentiated set of orange components to quickly and easily differentiate them from Genesis containers indented for other sterilization processes. The line provides long-lasting protection and sterility maintenance for surgical instrumentation. Genesis containers are offered in a variety of sizes to help organize and secure instruments prior to surgery. Genesis containers also provide an environmentally friendly alternative to sterilization wrap.

A press release can be found from BD website following this link.

FDA approved AtriCure Cryoablation Probe

AtriCure, Inc received 510(k) clearance for the cryoFORM cryoablation probe, which offers increased probe flexibility to adapt to a variety of surgical ablation procedures. The probe was previously launched in October 2015 in the European market under a CE mark.

“We are excited to bring this new technology to the U.S. market,” said Mike Carrel, President and CEO of AtriCure. “Since the launch in Europe, we have received very positive feedback from our customers, and are looking forward to continued growth in our cryoablation platform.”

The cryoFORM probe builds off of the company’s core strengths in cryoablation technology, leveraging such important features as thermal capacity to remove heat and active defrost, which offers the increased probe flexibility necessary for minimally invasive cardiac surgeries. Building upon those strengths, the new probe offers increased flexibility, allowing the surgeon to more easily manipulate and apply the device and conform to challenging anatomies.

“The flexibility of cryoFORM, together with the automatic defrost function of the CryoICE system, made us decide at the Heart Center Leipzig to start using this product for our cryoablation procedures,” said Dr. Martin Misfield, MD, PhD, Professor and Co-Director, Department of Cardiac Surgery, Heart Center, University of Leipzig.

Product brochure can be downloaded from AntriCure website by clicking here.

Boston Scientific Receives FDA Approval For MR-Conditional Pacing System

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.

The newly-approved family of INGEVITY MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.

Approval of the INGEVITY MRI leads, as well as the full ImageReady System, was based on data from two global clinical trials. The INGEVITY trial, a prospective, non-randomized study, enrolled 1,036 patients and assessed safety, performance and effectiveness of the leads in patients with a single or dual chamber pacemaker. The SAMURAI trial, a prospective, randomized study, enrolled 351 patients and evaluated safety and effectiveness of the ImageReady System for use in patients with a single or dual chamber pacemaker when used in an MRI environment.

The ImageReady System offers automatic daily monitoring via the LATITUDE™ NXT Patient Management System. An increasingly important tool for physicians, automatic daily monitoring has been shown to improve survival in patients with pacemakers1. The LATITUDE NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.

A press release can be found from Boston Scientific webstie following this link.

Microscope uses artificial intelligence to find cancer cells more efficiently

Scientists at the California NanoSystems Institute at UCLA have developed a new technique for identifying cancer cells in blood samples faster and more accurately than the current standard methods.
 

In one common approach to testing for cancer, doctors add biochemicals to blood samples. Those biochemicals attach biological “labels” to the cancer cells, and those labels enable instruments to detect and identify them. However, the biochemicals can damage the cells and render the samples unusable for future analyses.

There are other current techniques that don’t use labeling but can be inaccurate because they identify cancer cells based only on one physical characteristic.

The new technique images cells without destroying them and can identify 16 physical characteristics — including size, granularity and biomass — instead of just one. It combines two components that were invented at UCLA: a photonic time stretch microscope, which is capable of quickly imaging cells in blood samples, and a deep learning computer program that identifies cancer cells with over 95 percent accuracy.

Deep learning is a form of artificial intelligence that uses complex algorithms to extract meaning from data with the goal of achieving accurate decision making.

The new microscope overcomes those challenges using specially designed optics that boost the clarity of the images and simultaneously slow them enough to be detected and digitized at a rate of 36 million images per second. It then uses deep learning to distinguish cancer cells from healthy white blood cells.

The researchers write in the paper that the system could lead to data-driven diagnoses by cells’ physical characteristics, which could allow quicker and earlier diagnoses of cancer, for example, and better understanding of the tumor-specific gene expression in cells, which could facilitate new treatments for disease.

News source: UCLA

Profound Medical receives CE Mark for minimally invasive therapy in prostate care

Profound Medical announced that the company has received CE Mark approval for the commercial sale of TULSA-PRO.

“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. This is a major step forward in the growth of the company, facilitating the commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions. We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with TULSA-PRO,” said Steve Plymale, CEO.

Profound’s novel technology combines real-time Magnetic Resonance (MR) imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control, providing a highly precise treatment tailored to patient-specific anatomy and pathology.TULSA-PRO has demonstrated accurate and precise ablation of prostate tissue, both malignant and benign, while providing a favourable safety profile and a low rate of erectile dysfunction.

Profound Medical GmbH, a subsidiary of Profound Medical Corp., has been established in Hamburg, Germany to support European commercial operations. The commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions will commence immediately.

Product information can be found from Profound Medical website by clicking here.

Miniature fluorescence microscopy platform for imaging neural circuits launches commercially

Inscopix has brought its nVista brain imaging platform—which can view upwards of 1000 neurons simultaneously in one field of view—to market. Originally only accessible through the Neuroscience Early Access Program (NEAP), Inscopix plans to expand the system's reach to the widest spectrum of neuroscience investigators through packages customized for specific researcher needs.


Centered on a patented miniature microscope technology from Stanford University (California), the nVista system can decode the neural language underlying brain function and behavior. With the microscope, a tiny fluorescence camera can be implanted in hard-to-reach areas of a freely moving animal's brain and record millisecond-by-millisecond movies of the activity of large neural networks over days or several months.

Since the launch of NEAP in 2012, Inscopix disseminated nVista to over 100 early-adopter labs that played a crucial role in maturing the platform through feedback and scientific validation for its incorporation into standard neuroscience practice. NEAP researchers have published close to 20 research articles with the system in journals such as Neuron,Nature, and Cell, that provided deeper insights into multiple aspects of brain function, including motivation, learning and memory, and goal-directed behaviors. nVista also led to Inscopix's recognition by the World Economic Forum as a "Technology Pioneer" in 2015.

Product information can be found from Inscopix website by clicking here.

Planmed digital breast tomosynthesis system receives CE mark

The Planmed Clarity 3D digital breast tomosynthesis system and the Planmed Clarity™ 2D full field digital mammography system have received the CE mark and are now available for sale in the EU and other countries where the CE mark applies. The systems have also won the prestigious Red Dot Design Award.

Digital breast tomosynthesis produces a 3D volume of the breast and resolves the challenge of overlapping tissue structures. This results in enhanced diagnostics, especially for patients with denser breast tissue. Planmed’s patented new tomosynthesis method significantly improves image accuracy and allows even the smallest details to be captured with great precision.

In addition to the Planmed Clarity 3D digital breast tomosynthesis system, the new product family also includes the Planmed Clarity 2D digital mammography system, which can be easily upgraded to digital breast tomosynthesis at any time. Both systems allow imaging with a low effective patient dose and feature a durable digital detector for mobile screenings, as well as the new Planmed Clarity Flow touch control with dual touchscreens.

More details can be found from Planmed website by clicking this link.

Brain stimulation may reduce anorexia symptoms

Core symptoms of anorexia nervosa, including the urge to restrict food intake and feeling fat, are reduced after just one session of a non-invasive brain stimulation technique, according to King’s College London Research.

This new study is the first randomised control trial to assess whether repetitive transcranial stimulation (rTMS), already an approved treatment for depression, is also effective in reducing symptoms of anorexia.

Up to 20 per cent of people with anorexia die prematurely from the disorder and treatments in adults are moderately effective, with only 20-30 per cent of people recovering from the best available talking therapies.

Given the urgent need to improve treatments, researchers are increasingly looking towards emerging neuroscience-based technologies that could target the underlying neural basis of anorexia.

In the study, 49 people completed food exposure and decision-making tasks, both before and after a session of either real or placebo rTMS. Symptoms of anorexia were measured immediately prior to and following rTMS, as well as 20 minutes and 24 hours after the session.

This study represents independent research part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London.

For more details please visit King's College London Research website by clicking here.

Firefighters' positioning system may be used to monitor walking difficulty for elderly

A positioning system adapted for use in fire rescue operations will soon be tested on senior citizens in Sweden as a way to spot signs of early stage Parkinson's disease and other mobility Problems.

Inside the heel of a boot, advanced sensors designed at KTH Royal Institute of Technology in Stockholm make it possible for emergency operations commanders to follow smoke divers' exact movements in any building — even 25 metres below ground. The system, which includes an accelerometer and gyroscope, plus a processor, can withstand shock and high temperatures and remains operational where GPS positioning systems fail.

The small sensor in the shoe carefully measures the movement of the foot and directional changes, whether the user walks, runs, jumps or crawls. So, there are more potential uses for the technology. For example, behavioral research could take advantage of the data on people's movements.

Sports is another area where positioning technology can be useful. Athletes can measure their own movements and analyse whether these can be optimised to improve performance or to reduce damage.

The Open Shoe Project started as a joint collaboration between KTH and the Indian Institute of Science (IISc), Bangalore. It is now run within SAATH (Seamless affordable assistive technology for health), which is a Indo-Swedish project with KTH, University of Gävle, Robotdalen and Brepus Castel AB as Swedish partners, and IIT Kanpur and IISc as Indian partners.

More details can be found from KTH Royal Institute website by clicking here.

Stryker acquired vertebral compression fracture portfolio from BD

Stryker Corporation announced it has completed the acquisition of the CareFusion vertebral compression fracture (VCF) portfolio of products from BD (Becton, Dickinson and Company) in an all cash transaction. The portfolio is comprised of minimally-invasive systems used in vertebroplasty and vertebral augmentation procedures. BD acquired these assets as a part of CareFusion's portfolio in March of 2015.

"The acquisition of BD's VCF portfolio is highly complementary to Stryker Instruments' Interventional Spine (IVS) business and is aligned with IVS's strategy of expanding its VCF footprint," stated Timothy J. Scannell, Group President, MedSurg and Neurotechnology. "It also further strengthens Stryker's brand in the Neurotechnology space."

With this acquisition, Stryker can provide its customers a comprehensive product portfolio containing some of the least minimally invasive vertebral compression fracture treatment options available today and expand its presence in key markets with products that complement and enhance Stryker's current offerings.

The press release can be found from Stryker website by clicking here.

Boston Scientific Received CE Mark For MRI Labeling Of S-ICD Systems

Boston Scientific has received CE Mark approval for the new EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.

The EMBLEM S-ICD Systems are treatment options for patients at risk of sudden cardiac arrest (SCA) that leave the heart and vasculature untouched, reducing the risk of complications associated with transvenous implantable cardioverter-defibrillators (TV-ICDs). Initial market release of the new EMBLEM MRI S-ICD System has begun in a small number of European centers with a broad European launch scheduled for early this summer.

In Europe, the EMBLEM MRI S-ICD System joins the growing family of ImageReady™ MR-conditional devices, all of which are labeled safe for use in a magnetic resonance image setting when conditions of use are met. Patients receiving the EMBLEM MRI S-ICD System as well as patients who previously were implanted with an EMBLEM S-ICD System are now able to undergo full-body MR scans safely in 1.5 Tesla environments when conditions of use are met.

"These approvals give reassurance to physicians and their patients that they have access to any future MR scan needs, and underscores the Boston Scientific commitment to gain MR-conditional labeling on high-voltage devices that are being implanted today," said Kenneth Stein, M.D., chief medical officer, Rhythm Management, Boston Scientific. "Further, the EMBLEM S-ICD System is a compelling treatment option for the majority of ICD-indicated patients that provides protection from cardiac arrest without invading the heart and blood vessels."

The EMBLEM MRI S-ICD System also includes two new features, SMART Pass technology and Atrial Fibrillation (AF) Monitor™. The SMART Pass technology will help ensure patients receive therapy from the device only when necessary by enhancing the INSIGHT™ Algorithm, which identifies and classifies a heart rhythm for effective arrhythmia treatment. This novel feature will also be added to previously implanted EMBLEM S-ICD Systems through a software update. The AF Monitor feature of the EMBLEM MRI S-ICD System is a new detection tool designed to alert physicians after the identification of AF so they can make more informed treatment decisions for their patients.

For more information on the EMBLEM S-ICD Systems please visit www.sicdsystem.com.

First computer program to detect DNA mutations in single cancer cells

Researchers at The University of Texas MD Anderson Cancer Center have announced a new method for detecting DNA mutations in a single cancer cell versus current technology that analyzes millions of cells which they believe could have important applications for cancer diagnosis and treatment. The results are published in the April 18 online issue of Nature Methods.

Existing technology, known as next-generation sequencing (NGS), measures genomes derived from millions of cells versus the newer method for single-cell sequencing, called Monovar. Developed by MD Anderson researchers, Monovar allows scientists to examine data from multiple single cells. The study was, in part, funded by MD Anderson’s Moon Shots Program, an unprecedented effort to significantly reduce deaths from cancer.

This led to development of newer technology, called single cell sequencing (SCS), that has had a major impact in many areas of biology, including cancer research, neurobiology, microbiology, and immunology, and has greatly improved understanding of certain tumor characteristics in cancer. Monovar improves further on the new SCS’s computational tools which scientists found “lacking” by more accurately detecting slight alterations in DNA makeup known as single nucleotide variants (SNVs).

Full news coverage can be found from  The University of Texas MD Anderson Cancer Center Website.

St. Jude Launches New EnSite Precision Cardiac Mapping System in 9 European Countries

St. Jude announced expansion of its EnSite Precision™ cardiac mapping system limited market release in Europe and use of the new platform in more than 600 cases in nine countries since receiving CE Mark in January 2016. The mapping system is a next-generation platform designed to provide automation, flexibility and precision for tailored treatment in patients with cardiac arrhythmias. The launch constitutes introduction of an entirely new suite of technologies including innovations in hardware, catheters, surface electrodes (patches) and software features designed for improved ease of use. The system is currently available and expanding in select European countries as part of its initial launch and the company is currently pursuing U.S. Food and Drug Administration (FDA) clearance of the EnSite Precision cardiac mapping system.

The EnSite Precision cardiac mapping system is used in ablation procedures to visualize and navigate catheters in the heart. The system provides highly detailed anatomical models and maps to enable diagnosis of a wide range of arrhythmias, guide therapy and provide expanded procedural options to tailor care for patients. During this initial launch, the EnSite Precision cardiac mapping system was used in a variety of procedures, from simple to complex, including atypical flutter, paroxysmal and persistent atrial fibrillation (AF), and ventricular tachycardia (VT), with excellent system performance through challenging procedure dynamics.

The EnSite Precision cardiac mapping system uses intelligent automation tools to enable faster, more accurate high-density maps with greater consistency across cases. The system is flexible and enhances efficiency by allowing physicians to map heart chambers with any electrophysiology catheter and customize procedures to address the circumstances of each case. The EnSite Precision cardiac mapping system allows catheter navigation to occur with less fluoroscopy, thus reducing potential for risks associated with excessive radiation exposure.

New release from St. Jude can be found from their website by clicking here.

China's Venus Medtech aquires tech portfolio from German Transcatheter Technologies

Transcatheter Technologies GmbH, a medical device company that has developed a full range of transcatheter valve implantation systems for catheter-based heart valve therapy, announced today that it has sold its technology portfolio to Venus Medtech. The Transcatheter Technologies’ technology will be the basis of a next generation product portfolio developed and marketed by Venus Medtech for the Chinese and international markets.

Under the agreement, Transcatheter Technologies’ co-founders, CEO and cardiac surgeon Dr. Wolfgang Goetz, M.D., and CTO and engineer Hou-Sen Lim will assist Venus Medtech with the transition and commercialization of the acquired technology for up to three months. Venus Medtech (HangZhou) Inc. develops and manufactures an advanced interventional artificial cardiac valve system. Venus Medtech is a leading heart valve developer in China. Its transcatheter aortic valve has completed clinical trials and follow up, pending China CFDA approval. Its transcatheter pulmonic valve is completing its clinical trials. Both of the valves are expected to be the first transcatheter valves approved in China. They are also developing the next generation heart valves with pre-crimping technology. Venus Medtech sets its goal as a worldwide transcatheter heart valve company. With its clear vision, last month, Venus Medtech announced an investment of $37 million from Goldman Sachs to support R&D and marketing activities for Venus Medtech’s cardiac valve products.

News release can be found from Transcatheter Technologies website following this link.

Fractyl receives CE for duodenal mucosal resurfacing to treat metabolic diseases

Fractyl Laboratories announced that the Company’s Revita DMRTM System, used to perform minimally invasive duodenal mucosal resurfacing for the treatment of metabolic diseases (Revita DMR procedure), has received European CE Mark approval. The announcement was made during a company presentation of new data in liver disease at the 2016 International Liver Conference of the European Association for the Study of Liver (EASL) in Barcelona, Spain. Fractyl’s presentation, “Endoscopic duodenal mucosal resurfacing (DMR) improves metabolic measures including hepatic transaminase levels in patients with type 2 diabetes (T2D): Data from a first-in-human study,” included new data that a single Revita DMR treatment improved metabolic control in patients with both type 2 diabetes and fatty liver disease. The results presented included a lowering of hepatic transaminase levels, sustained through six months of follow up.

“Both CE Mark approval and the first opportunity to share our early results in liver disease are major milestones for Fractyl and for our clinical and research partners. This is the first of several presentations on Revita DMR that will take place over the next two months across the major endocrinology, GI and diabetes conferences,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl.

CE Mark approval gives Fractyl the opportunity to commercialize Revita DMRTM in the European Union for the treatment of metabolic diseases such as type 2 diabetes and fatty liver disease. CE Marking confirms that Revita DMR has met the requirements of the European Medical Devices Directive.

In 2015, Fractyl announced results from 39 patients with poorly controlled type 2 diabetes in a single-site, proof-of-concept study in which beneficial changes in blood sugar were observed following Revita DMR. The data presented at EASL from the same population expands on this previously announced data and suggests beneficial changes in markers of fatty liver disease following Revita DMR.

a press release can be found from Fractyl Website by clicking here.

Scope International AG opens office in Pittsburgh

Scope International AG has expanded by opening a new office in the United States of America. The new office is located in the heart of North East Region in Pittsburgh, Pennsylvania.

Scope International is an innovative full-service, science-focused Clinical Research Organization (CRO) with over 15 years of experience in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. SCOPE offers comprehensive clinical development services, including project management, clinical monitoring, data management, biostatistics and medical writing for a single study or an entire clinical program.

The Scope International team is known for its friendly and professional communications as well as for their passion for science and providing quality solutions. Due to SCOPE‘s unwavering commitment to scientific integrity, client focus and exceptional performance, SCOPE enjoys an enviable reputation from satisfied clients. SCOPE’s business in Europe has grown substantially with an expanding number of offices, strong partnerships and the participation in many successful clinical development programs, leading to market authorizations.

The Pittsburgh office expansion was warranted by this growth. “The new office represents our commitment towards our continued growth through strengthened operational capabilities. We are dedicated to maintain and expanding our competences and expertise across the U.S. and Canada in order to address the diverse needs of our clients.” said Gerald Meub, CEO. “After having evaluated some potential locations we are fortunate to eventually have discovered Pittsburgh.

A press release can be found from Scope website by clicking this link.

Direct Flow Medical Launches Transcatheter Aortic Valve System in Europe

Direct Flow Medical announced European commercial market launch of the DirecTrack™ Delivery System, a next generation delivery system for the Direct Flow Medical Transcatheter Aortic Valve System.

The Direct Flow Medical transcatheter aortic valve system, with more than 2,500 implants and excellent published clinical results including low rates of paravalvular leak, pacemaker implant, and mortality, is the only non-metallic, conformable transcatheter aortic valve that can be functionally assessed, repositioned, and retrieved prior to final implant.

The next generation DirecTrack Delivery System features advanced ergonomic design and functionality to provide physicians with greater procedural control during valve implantation. “I have had the opportunity to use every generation of the Direct Flow Medical delivery system since its inception. The new DirecTrack system is a major step forward in positioning control and smooth valve delivery” stated Joachim Schofer, M.D., Professor of Cardiology, Hamburg University Cardiovascular Center, Hamburg. He continued, “I’m impressed with the additional procedural efficiency gained, making it faster and easier to achieve an optimal outcome.”

“We’re pleased to provide physicians with this latest advance in TAVI procedural control” stated Dan Lemaitre, President and CEO, Direct Flow Medical. He said, “The DirecTrack Delivery System provides all the features of our prior delivery system but with significantly enhanced ergonomics and precision to assure the best possible clinical outcome.”

A press release can be found from Direct Flow Medical website by clicking here.

St. Jude Launches First US Implants of MultiPoint Pacing

St. Jude received U.S. Food and Drug Administration (FDA) approval of the company’s proprietary, first-to-market MultiPoint™ Pacing technology and today announced the U.S. launch and first U.S. implants of the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). MultiPoint Pacing technology is a revolutionary approach designed for CRT patients who are not responsive to other pacing options.

The first implant took place at Saint Francis Hospital in Hartford, Conn. Speaking about the opportunity, Dr. Neal Lippman, electrophysiologist with Arrhythmia Consultants of Connecticut at Saint Francis said, “We are now able to offer St. Jude Medical’s new MultiPoint Pacing technology for our patients whose heart failure condition is difficult to manage. It is important for us to have this option to individualize patient care and help improve response to therapy.”

Despite the improvements in patient outcomes seen with quadripolar CRT technology, a small, but important group of patients do not respond optimally to the therapy. Importantly, these “non-responders” to CRT cannot be identified at the time of implant and how effective the therapy will be in addressing an individual patient’s heart failure symptoms can be unpredictable. MultiPoint Pacing technology offers physicians a new set of tools that allow for individualized patient therapy with the goal of optimizing their response to CRT.

St. Jude Medical developed and launched the industry’s first quadripolar pacing system in the United States in 2011 featuring four pacing electrodes, offering physicians the ability to effectively and efficiently manage the ever-changing needs of patients with heart failure. The Quartet LV lead design allows the physician to implant the lead in the most stable position without making trade-offs in electrical performance; this also reduces the likelihood of costly and invasive lead revision through a second intervention procedure. Adding MultiPoint Pacing technology and additional lead sizes to the quadripolar offerings provides physicians more advanced options to optimize CRT performance, such as improving hemodynamics, resynchronization and reverse remodeling of the heart.

The press release can be found from St. Jude website by clicking here.

BIOTRONIK Receives FDA Approval of Insertable Cardiac Monitor

Biotronik announced Food and Drug Administration (FDA) approval of BioMonitor 2, an insertable cardiac remote monitor with ProMRI® technology.

BioMonitor 2 is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. The device can also be used to monitor atrial events in patients who have undergone ablation procedures.

BioMonitor 2 is inserted subcutaneously through a minimally invasive process under local anesthesia. The device provides a flexible antenna and positioning, adapting easily to a patient’s anatomy, while providing unmatched sensing amplitude that ensures reporting accuracy. BioMonitor 2 also features BIOTRONIK’s ProMRI technology, ensuring patients have access to full-body magnetic resonance imaging (MRI) scans (both 1.5T and 3.0T) as needed throughout their lifetime.

More info can be found from Biotronik website by clicking this link.

Dexcom Recalls G4 Platinum and G5 Mobile Continuous Glucose Monitoring System

Dexcom Inc. is recalling the Continuous Glucose Monitoring Systems because the audible alarm may not activate in the receiver piece when low or high glucose levels (hypoglycemia or hyperglycemia) are detected.

Relying on this product for notification of low or high blood sugar could result in serious adverse consequences, including death as the auditory alarm may not sound and users might not be notified of low or high blood sugar.

Dexcom, Inc. issued a press release on 11 April, 2016 to supplement its previous customer notification and remind its patients to periodically test the audible alarms and alerts on certain receivers manufactured by Dexcom to make sure that the audible alarms and alerts are functioning properly. The notification constituted a voluntary recall and applied to those Dexcom G4 Platinum Receivers, Dexcom G4 Platinum Pediatric Receivers, Dexcom G4 Platinum Professional Receivers, Dexcom G4 Platinum with Share Receivers, Dexcom G4 Platinum with Share Pediatric Receivers and the Dexcom G5 Mobile Receivers that are experiencing problems with audible alarms and alerts. There is no reason for patients to return receivers to Dexcom that are functioning properly.

Dexcom issued the customer notification on February 23, 2016 via its website and certified mail to patients. The notification alerted customers of a potential issue affecting the audible alarms and alerts associated with the speaker component of certain receivers. Dexcom notified customers about this potential issue after receiving customer complaints about the receivers' speaker component. Specifically, the speaker failed to properly provide audible alerts and alarms in some or all instances.

Customers who rely on audible alerts and alarms may not be notified of severe hypoglycemia or hyperglycemia if the speaker in their receiver does not function properly. The immediate health consequences of severe hypoglycemia include loss of consciousness, seizure, and in rare instances death.

The FDA has identified this as a Class I recall, the most serious type of recall. Relying on this device may cause serious injuries or death.

Recalled Devices
Name of device: Dexcom G4 PLATINUM Receiver, Dexcom G4 PLATINUM (Pediatric) Receive, Dexcom G4 PLATINUM (Professional) Receiver, Dexcom G4 PLATINUM Receiver with Share, Dexcom G4 PLATINUM (Pediatric) Receiver with Share, Dexcom G5 Mobile Receiver
Model numbers: all models
Lot numbers: all lots
Manufacturing dates: July 29, 2011 to March 10, 2016
Distribution dates: October 22, 2012 to March 10, 2016
Devices recalled in the U.S.: 263,520 units nationwide

More information can be found from FDA website by clicking below links:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm495448.htm

http://www.fda.gov/Safety/Recalls/ucm495481.htm

CardiacAssist Announces Rebranding as TandemLife

CardiacAssist, Inc. announced a rebranding of the privately-held company and will begin to do business as TandemLife as it rolls out several new product lines to hospitals worldwide. Following the FDA clearance of its TandemLung® oxygenator, the new TandemLife company is focused on making advanced cardiac and respiratory support technology available to more patients by providing medical devices that deliver on its mission of Life Support Simplified™.

In North America, less than 2% of patients who experience a cardiac or respiratory emergency currently receive care with advanced cardiopulmonary support, in part because the complexity of such therapy has restricted its use to only the largest, most advanced hospitals. With TandemLife, hospitals can deploy a single pump and controller platform upon which all of the company’s products operate, eliminating the need to train and certify hospital staff on multiple different systems. For cardiac support, a physician may choose the classic TandemHeart procedure, the ProtekDuo procedure available since late 2014, or the new TandemLife procedure, depending on each patient’s individual needs. Likewise, for patients experiencing respiratory dysfunction, either the TandemLife or TandemLung procedures may be appropriate. By offering multiple circulatory support options on a single platform, hospitals can turn to TandemLife as a premier, single-source provider of a comprehensive system to control healthcare costs without sacrificing the quality of care.

More nformation can be found from TandemLife website by clicking this link.

FDA Approves Minimally Invasive Solution for Chronic Tendinosis from Tenex Health

Tenex Health has obtained FDA 510K clearance for its new TX2 MicroTip. The TX2 MicroTip will be primarily utilized to address tendinosis of the shoulder and hip, two areas that were more difficult to reach using the original TX1 MicroTip due to its length. Tendinosis of the shoulder and hip affects approximately 5 million persons in the US alone every year. The company plans to make the TX2 MicroTip available in mid-2016 as a minimally invasive out-patient solution for patients who suffer from soft tissue pain.

The TX2 MicroTip is a disposable surgical instrument that uses ultrasonic energy to specifically cut and remove targeted soft tissue. The extended length of the TX2 MicroTip, at 2 inches long, will allow physicians to complete a percutaneous tenotomy in regions of the body not typically accessible by the shorter TX1 instrument.

More information can be found from Tenex website by clicking here.

German 3D Printing Technology for Building Complex Multi-Material Medical Devices

The researchers from Fraunhofer Institute for Ceramic Technologies and Systems (IKTS) in Dresden are focusing on suspension-based additive manufacturing methods and combinations of them with other manufacturing techniques to create not only microreactors, but also bone implants, dentures, and surgical tools.

This German 3D printing technology offers solution for creating medical components in almost every conceivable design using additive manufacturing methods.“We have no limitations in terms of type or color of material for the target components. This allows us to process ceramics, glass, plastic, or even metal using thermoplastic 3D printing. One more advantage is that several different materials can be produced at the same time,” says Dr. Tassilo Moritz from Fraunhofer IKTS’s “Materials and Processes” business division. In the lab, the scientists have already successfully made components out of high-performance ceramics and hard metals. Now they are looking for partners to put their technology to real-world use.

One area in which the multi-material approach is important is surgery: endoscopes frequently employ an instrument to first cut open tissue, and then quickly close the blood vessels back up again using electric current. To prevent electricity from shocking the patient, the instrument needs not only high-grade steel but also insulated ceramic components. ”Ceramic substances are often well-suited for medical devices and components. Ceramics are sturdy and can be cleaned thoroughly,” explains Moritz.

The press release can be found from IKTS Website by clicking this link.

FDA allows the first tissue containment system for use with certain laparoscopic power morcellators

Advanced Surgical Concepts, an Irish comapny, announced that the U.S. Food and Drug Administration (FDA) permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer, Advanced Surgical Concepts, to warn patients and health care providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.

The PneumoLiner is intended to be used only in a limited patient population, including women without uterine fibroids undergoing hysterectomy and some pre-menopausal women with fibroids who want to maintain their fertility; a small number of women may find, after consultation with their doctor, that laparoscopic power morcellation is an appropriate therapeutic option compared to more invasive surgery. For these women, the device is intended to isolate and contain tissue that is considered to be non-cancerous before surgery even if that tissue is subsequently determined to be cancerous.

The device consists of a containment bag and a tube-like plunger to deliver the device into the abdominal cavity where the tissue to be removed is placed in the bag and the bag is sealed and inflated. Inflation allows for the creation of a working space around the tissue and visualization during morcellation to help prevent breakage of the containment bag by the morcellator tip or other surgical instruments. It was tested in laboratory settings to simulate actual use and worst-case scenario conditions. The containment bag was found to be impermeable to substances that were similar in molecular size to tissues, cells and body fluids, and other testing determined that the inflated bag provided adequate space for surgeons to perform morcellation with good visualization. Stress testing to evaluate the bag’s mechanical strength demonstrated that the device could withstand forces in excess of those expected to occur in actual clinical use.

Risks associated with the PneumoLiner device include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections and a prolongation of the surgical procedure. The required labeling for the device must state that use of the device is limited to physicians who have successfully completed the company’s validated training program.

The press release can be found from Advanced Surgical Concepts by clicking here.

Boston Scientific initiated global voluntary recall of Fetch™ 2 Aspiration Catheter

Boston Scientific has initiated a global, voluntary recall of all models of its Fetch™ 2 Aspiration Catheter, a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries. The Fetch 2 catheters were recalled on March 22, 2016, due to complaints of shaft breakage. The U.S. Food and Drug Administration (FDA) classified the action as a Class 1 recall. This recall designation means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.

There have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter. All reports of shaft breakage happened during the procedure, and the broken section was either removed while still partially attached to the catheter shaft or retrieved with a snare, without further patient complications. While unreported, the most severe potential outcome of this breakage is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment surgically. 

As part of the recall, all affected healthcare facilities were advised to discontinue use of all Fetch 2 catheters immediately and return unused product to Boston Scientific. Because Boston Scientific acquired the Fetch 2 catheter product line from Bayer Medical Care Inc., all recalled inventory is packaged and labeled as Bayer product. This device was manufactured between June 11, 2014 and February 19, 2016. There are currently 21,155 devices on the market subject to this recall.

Fetch 2 Catheter UPNs

FETCH2 US 109400-001

FETCH2 OUS 109400-002

FETCH2 Canada 109400-003

FETCH2 Japan 109400-004

FETCH2 EU 109400-005

To get more Information, please visit Boston Scientific website by clicking here.

Philips Volcano announces more than 5,000 Coronary Artery Disease patients enrolled in iFR Outcomes Trials

Philips announced that a combined total of more than 5,000 patients have been enrolled in three prospective clinical studies to assess the safety of deferring cardiovascular interventions using Philips Volcano’s proprietary iFR (instant wave-Free Ratio) pressure measurement technology versus conventional FFR (Fractional Flow Reserve) measurements.

During catheterization procedures to assess and treat a patient’s coronary arteries, a guide wire is used to obtain measurements of the blood pressure at specific points inside the affected arteries to help assess the severity of the blockage(s). There is a growing body of clinical evidence that the use of FFR in conjunction with interventional X-ray helps improve procedure outcomes, and reduces healthcare costs.

Full coverage can be found from Philips website by clicking here.

CFDA approves 2 non-invasive fingertip mounted device from CNOGA

CNOGA Medical has received China CFDA approval for two of their non-invasive fingertip devices for detection of bio-parameters.

One product is named as the MTX, a novel Non-Invasive Fingertip mounted device designed to measure a wide range of physiological bio-parameters without the need to take painful invasive blood samples.

Based on tissue photography analysis of the fingertip capillaries, a single MTX device can analyze more than 14 different bio parameters within seconds. Combining the MTX with Cnoga’s mobile application and cloud-based services provides health care professionals and organizations with an easy access to medical data for better disease management thus enabling true ongoing remote monitoring.

The other product is the so called VSM cuff-less, simple to use, portable device which can measure blood pressure, pulse, blood Oxygen saturation and also fits into your pocket. Cnoga’s unique technology enables continuous blood pressure measurements without the need of using an arm cuff and air pressure.

Hunan Province to build its first 'cloud hospital'

Hunan Province, China, will build its first 'could hospital' in Changsha City, capital city of Hunan Province.

The new hospital will integrate services for chronical diseases patients including gene test, blood pressure real time online monitoring, tele-medicine. The target of this new ‘cloud hospital’ is to serve around 3 million patients with chronical diseases yearly.

St. Jude Launches First Commercial DRG Stimulation Therapy Implant in USA

St. Jude announced the U.S. launch and first post-approval implants of the St. Jude Medical Axium™ Neurostimulator System for dorsal root ganglion (DRG) stimulation to treat patients with chronic pain that has been hard to control with traditional spinal cord stimulation (SCS). First commercial implants of the device occurred at the Center for Pain Relief in Charleston, W.Va. by Dr. Timothy Deer, and at the Sutter Santa Rosa Surgery and Endoscopy Center in Santa Rosa, Calif., by Dr. Jason Pope.

In the coming weeks, DRG implants will occur in half the states in the United States. St. Jude Medical has already partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. Over the course of the year, the company expects to have more than 300 physicians across the country trained to effectively deliver DRG therapy to patients in immediate need of targeted stimulation to alleviate chronic pain resulting from moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.

According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Neuropathic pain represents one of the most prevalent yet under-treated forms of chronic pain in the United States, with an estimated one in every 10 adults over the age of 30 suffering from the condition.

Initial results from the ACCURATE IDE study, the largest study to date evaluating patients suffering from neuropathic chronic intractable pain associated with CRPS I and II or peripheral causalgia (PC), showed DRG stimulation provided patients with superior pain relief over traditional tonic SCS. Approval of DRG stimulation with the St. Jude Medical Axium Neurostimulator System was based in part on the results of this study in which patients were randomized to receive either DRG stimulation delivered by the Axium neurostimulator system or traditional tonic SCS therapy delivered by a competitor’s system.

For more information, please visit St. Jude website by clicking here.

Earlier news: St. Jude Medical Announces the European Launch of the Trifecta Surgical Valve with Glide Technology

FDA Approves World's Smallest yet Leadless Pacemaker

Medtronic announced it has received U.S. Food and Drug Administration (FDA) approval of the world's smallest pacemaker, the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart -providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).

Comparable in size to a large vitamin, the Micra TPS is attached to the heart with small tines and delivers electrical impulses that pace the heart through an electrode at the end of the device. Unlike traditional pacemakers, the Micra TPS does not require leads or a surgical "pocket" under the skin, so potential sources of complications related to such leads and pocket are eliminated-as are any visible signs of the device. The device responds to patients' activity levels by automatically adjusting therapy.

Micra TPS is the first and only transcatheter pacing system to be approved for both 1.5 and 3 Tesla (T) full-body magnetic resonance imaging (MRI) scans, providing patients with access to the most advanced imaging diagnostic procedures available.

The Micra design incorporates a retrieval feature to enable retrieval when possible; however, the device is designed to be left in the body. For patients who need more than one device, the miniaturized Micra TPS was designed with a unique feature that enables it to be permanently turned off so it can remain in the body and a new device can be implanted without risk of electrical interaction.

Further info can be found from Medtronic website by clicking this link.

Also in news: St. Jude obtains CE approval for MRI Compatible Nanostim Leadless Pacemaker

Miniaturized Electromagnetic Device from MagDent

MagDent has developed its first product – Miniaturized Electromagnetic Device (MED) small enough to fit most dental implants. MED is easily screwed into the implant and removed at the end of the treatment period using regular protocols.




Magdent’s novel technology utilizes electromagnetic fields to stimulate, accelerate, and improve bone formation and quality for shorter, more successful dental implant procedures and suppresses bone infections – making it the only treatment in cases of Peri-implantitis and Peri-implant mucositis.

More info can be found from MagDent website by clicking this link.

Below product video is from MagDent.