ReliantHeart’s next-generation aVAD left ventricular assist device has just earned CE Mark approval and implants are set to begin in September.
The LVAD market is going through an evolution right now as major commercial players Thoratec and HeartWare have both been acquired by large medtech companies. Thoratec was acquired by St. Jude Medical last year; St. Jude Medical has since been purchased by Abbott ($ABT). Medtronic ($MDT) announced its acquisition of HeartWare in June.
Medtronic announced it has received CE (Conformité Européenne) Mark for SureTune2(TM) software, which provides patient-specific visualization to help physicians make decisions on how to program - or tune - their patient's deep brain stimulation (DBS) therapy. SureTune2 is currently not approved in the United States.
DBS therapy applies mild electrical stimulation to precise targets in the brain in order to modulate specific symptom control. The brain targets are stimulated through lead(s) inserted into the brain and connected to an implantable neurostimulator through extensions running under the skin. A medical professional uses an external programmer to set and adjust stimulation settings.
Today DBS patient programming can be an interactive process, which can be time- consuming for the hospital and the patient. SureTune2 is designed for Medtronic DBS therapy and other DBS therapy delivery systems to help physicians more efficiently select the optimal stimulation settings on their programmer by visualizing patient-specific information in one comprehensive view including anatomy, physiology, and calculated stimulation field. Users can segment structures using a greyscale threshold within a region of interest, or by outlining shapes of interest from a patient image.
"SureTune will have an important impact on the care of patients with deep brain stimulation because it allows me for the first time to visualize activation patterns of DBS within the individual segmented patient anatomy," said Professor Jens Volkmann, MD, PhD, FEAN, chairman and professor of neurology in the University Clinic of Würzburg. "It simplifies the trial and error process associated with DBS programming by helping me identify the best contacts, which saves me time."
"Medtronic is committed to providing advanced technology to the multidisciplinary teams who are helping DBS patients, and I'm convinced that SureTune will provide them with easy-to-use tools to aid in optimizing therapy outcomes," said Lothar Krinke, PhD, vice president and general manager of the Brain Modulation business in Medtronic's Restorative Therapies Group. "SureTune is a key aspect of Medtronic's commitment to providing integrated solutions for improving accuracy and confidence from surgery to post-operative DBS patient management."
Medtronic helped pioneer DBS, and more than 140,000 patients worldwide have received Medtronic DBS Therapy, which is approved in many locations around the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, Parkinson's disease and dystonia, the latter for which approval in the United States is under a Humanitarian Device Exemption (HDE). In Europe, Canada and Australia, Medtronic DBS therapy is approved for the treatment of refractory epilepsy. Medtronic DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in Europe and Australia, and in the United States under an HDE.
Pixium Vision announced that it has been awarded CE mark for its IRIS®II bionic vision system. This 150-electrode epi-retinal implant features a design intended to be explantable and upgradeable. The IRIS®II system is now CE mark approved for people with vision loss from outer retinal degeneration.
Christina Fasser, President of Retina International, an umbrella association of 33 national societies, said: “The progress in research with vision restoration of some visual perception is a reality, particularly with retinal prostheses. This research is addressing the growing patients’ expectations and their hope to regain some sight. On behalf of our member organisations, we are delighted to welcome the new bionic vision system IRIS®II that may offer people suffering from retinitis pigmentosa a new treatment option with a design that is intended to be explantable and upgradeable.”
The IRIS®II system is only available by medical prescription. Several leading ophthalmology centers in Europe are continuing to evaluate the system’s long-term performance based on a pre-defined protocol. The company is now able to file for national reimbursements.
Khalid Ishaque, CEO of Pixium Vision said: “The CE mark certification is a major step forward for Pixium Vision and for retinal dystrophy patients who have lost their sight. This recognition, by an independent expert body, validates the long-term multidisciplinary work that has resulted in market approval of the IRIS®II system. We will continue to develop our bionic vision systems with the aim to deliver improved visual perception and help retinal dystrophy patients lead more independent lives.”
In parallel, Pixium Vision is developing a tiny, wireless, sub-retinal photovoltaic implant for patients with AMD (age-related macular degeneration).
Medtronic announced it has received CE Mark for its new Guardian(TM) Connect mobile continuous glucose monitoring (CGM) system for people with diabetes using insulin injection therapy. Guardian Connect is the first smartphone-enabled CGM system from Medtronic to receive CE Mark and further demonstrates the company's intent to provide solutions for people across the diabetes care continuum. The system will be launched on a country-by-country basis in the second quarter of fiscal year 2017, beginning with select countries in Europe, Asia Pacific, and Latin America.
With Guardian Connect, people on insulin injections will be able to check their current glucose level anytime on their mobile device, as easily as checking other information sources such as email, the weather or social media. They can also be alerted of high and low glucose levels on their mobile device, helping them confidently avoid or address high and low glucose situations. Guardian Connect is the first and only mobile CGM system with customizable SMS text alerts enabling care partners to receive high and low glucose alerts on any connected mobile device. The system also features the option to automatically upload the data daily into CareLink(TM) therapy management software, which reduces the burden of data upload for both people on insulin injection therapy as well as their healthcare providers.
"Having continuous, real-time access to glucose values and being alerted to important trends and events is key for people with diabetes. With our new Guardian Connect system, we've continued to innovate so we can deliver these insights for people with diabetes on insulin injection therapy," said Annette Brüls, president, Diabetes Service and Solutions at Medtronic. "Guardian Connect is also compatible with our CareLink® diabetes therapy management platform and arms healthcare providers, their patients and care partners with actionable data to help improve day-to-day diabetes management and make long-term therapy adjustments. Expanding our solutions to help more people with diabetes no matter where they are on the care continuum is central to our goal of transforming diabetes care for greater freedom and better health."
The Guardian Connect system consists of a small wearable CGM device that takes glucose readings every five minutes (288 times a day) and sends these glucose values directly to a smartphone app. People on insulin injection therapy can use the system to check glucose levels on their mobile phones, enabling them to see highs and lows in real-time, understand the trends and help improve their daily management of diabetes. Alerts can also be set up if glucose levels go above or below preset levels, helping patients prevent or address potentially dangerous high and low glucose events. All of this information can be shared with care partners via SMS text messages and via access to the real-time CGM tracing from any web-enabled device. In addition, healthcare providers can leverage automatic daily data uploads via CareLink.
The Guardian Connect smartphone app will initially be available with iOS devices. Medtronic is currently developing an Android version of the Guardian Connect app for release at a later date. The Guardian Connect system is not yet available for sale in the United States.
QT Vascular Ltd announced that it has received CE mark clearance for the sale and distribution of the Chocolate Heart™ drug-coated PTCA balloon for dilatation of the stenotic portion of coronary arteries for the purpose of improving myocardial perfusion in Europe.
Chocolate Heart™ is the drug-coated version of the Company’s Chocolate® PTCA balloon that has been commercially available in the United States (“US”) since late 2014. Chocolate® PTCA features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus is designed to reduce acute trauma, dissections, and unplanned stenting compared to conventional balloons. Initial evidence of this has previously been demonstrated in a trial of the peripheral version of Chocolate® known as Chocolate® PTA (“Chocolate BAR”)1. The Company has added a proprietary coating containing the proven drug, paclitaxel, to the Chocolate® PTCA platform in order to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow certain patients to be treated with Chocolate Heart™ while avoiding the need for a permanent implant such as a metallic stent.
Drug-coated balloons represent a rapidly growing new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries in the leg. These devices have been available for several years in Europe and were recently approved in the United States. Since their approval in the U.S., adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates3, revenues for drug-coated peripheral balloons are expected to reach $1 billion by 2020. The Company believes that drugcoated balloons may also play an important role in the future in the treatment of patients with disease in their coronary arteries.
Axonics Modulation Technologies announced that it has received CE approval for its SNM System to treat Overactive Bladder (OAB), Fecal Incontinence and Urinary Retention.
The CE Mark confirms that the Axonics product meets all of the essential requirements of the European Medical Device Directive for Active Implantable Medical Devices and enables Axonics to market its SNM System throughout the European Union.
Axonics has also received ethics committee approval from select centers in Western Europe and will start a 65-patient post-market clinical follow up (PMCF) study.
The Company also announced that Neurourology and Urodynamics published the results of a peer-reviewed study titled, “Cost Profiles and Budget Impact of Rechargeable Versus Non-Rechargeable Sacral Neuromodulation Devices in the Treatment of Overactive Bladder Syndrome.” The study assesses the potential cost impact to U.S. healthcare payers of a rechargeable SNM system. Findings determined that compared to non-rechargeable SNM systems for the treatment of OAB, a rechargeable SNM system with a long-lived battery could save the U.S. healthcare system more than $12 billion over the next 15 years. Physicians and researchers collaborating on the study included Karen L. Noblett, MD, University of California, Riverside; Roger R. Dmochowski, MD, Vanderbilt University; Sandip P. Vasavada, MD, Cleveland Clinic, and Abigail M. Garner, MS; Shan Liu, PhD; Jan B. Pietzsch, PhD of Wing Tech, Inc., Menlo Park, CA.
“The Axonics device promises increased patient comfort given its small size. Moreover, the fact that it is rechargeable and can function three times longer in patients will eliminate the need for repeat surgeries that are currently required every four or five years to replace implanted devices with drained batteries,” said Prof. Karen L. Noblett, M.D., Chair of the Department of Obstetrics and Gynecology, University of California Riverside School of Medicine. “Our economic study findings clearly show the Axonics System has the ability to also lower healthcare costs. This potentially allows more patients to benefit from a therapy that has been proven over many years to improve the quality of life of patients suffering from urinary and fecal dysfunction.”
OAB affects an estimated 85 million adults in the US and Europe. Another 40 million are reported to suffer from fecal incontinence. SNM therapy is an effective and durable treatment that has been widely used and reimbursed in Europe and the US for the past two decades. Over 200,000 patients have benefited from the therapy to date. SNM is the only OAB treatment with proven clinical superiority to standard medical therapy and OAB patients who receive SNM report significantly higher quality of life than patients undergoing drug treatment.
“Axonics has successfully developed a unique product to deliver SNM therapy that we believe will greatly improve the patient and clinician experience,” said Raymond W. Cohen, Axonics’ Chief Executive Officer. “We look forward to treating patients in our upcoming PMCF study.”
Avenu Medical, Inc. announced today that it has received CE Mark approval for the commercial sale of its Ellipsys® Vascular Access System, an innovative, single catheter image-guided system designed to meet the 21st century needs of vascular access for hemodialysis. With this authorization, Avenu can now launch the technology at clinical centers of excellence throughout Europe.
A groundbreaking innovation for dialysis patients and clinicians, Avenu’s Ellipsys is the first medical device to be approved for study under an Investigational Device Exemption (IDE) by the FDA for minimally invasive creation of arteriovenous (AV) fistulas. The current gold standard of surgical fistula creation was established in 1966 and has not been significantly advanced since its inception 50 years ago.
News of Avenu receiving the CE Mark also comes on the heels of the company reaching full patient enrollment in its FDA-authorized pivotal phase III IDE clinical trial. This multi-center study is designed to demonstrate the safety and efficacy for the percutaneous creation of AV fistulas. The Company intends to file for FDA market authorization later this year.
Dialysis patients require consistent, effective, reproducible, and permanent vascular access. Meanwhile, surgical AV fistulas fail 40-60% of the time, often take several months to achieve usability and require multiple interventions to maintain functionality. In addition, patients often wait five months or longer to get a functioning surgical AV fistula. These factors result in the patients’ extended exposure to central venous catheters, which can lead to increased risks for infection and mortality. Avenu’s Ellipsys System introduces a modern alternative. Thanks to this new technology, clinicians now have a less invasive alternative to the creation of AV fistulas.
Roche announced that it has launched the CoaguChek® INRange system in countries accepting the CE Mark. The CoaguChek INRange system is the first Bluetooth enabled PT/INR home health device that helps patients and their healthcare providers (HCPs) have greater control over their coagulation status and the ability to monitor Vitamin K Antagonist (VKA) therapy. Patient self-testing with CoaguChek INRange sets a new standard of care by enabling HCPs to monitor patient PT/INR data, while reducing visits to the lab.
Frequent self-testing offers both clinical and patient benefit as it has been proven that patients that adhere to their monitoring therapy spend more time in their therapeutic range, which results in lower incidence of stroke1 or bleeding.2 It has been demonstrated that 50–60% of patients can be expected to remain in their target range if monitoring of INR occurs monthly, 77–85% if monitored weekly and up to 92% if monitored every three days.3 Patients who spend a high proportion of time (> 70%) in the therapeutic range achieve better clinical outcomes.4,5
Evidence suggests that patients who have a strong link with their healthcare professional adhere better to their anticoagulant therapy plan.3 The CoaguChek INRange system helps enhance the relationship between patients and their healthcare providers. Patients build a deeper understanding of their PT/INR results through frequent self-testing and physicians are more confident that they can optimise treatment decisions effectively as they have access to patient data in near real-time.
“As healthcare systems face continued pressure to deliver improved access to care at a lower cost, increased connectivity between HCPs and patients becomes even more important,” said Roland Diggelmann, COO, Roche Diagnostics. “This innovative technology continues the CoaguChek legacy of setting the standard in coagulation monitoring by providing high quality, convenient care, while optimising outcomes for patients. This is another proof point towards our aim to position patient self-testing as the standard of care to monitor VKA therapy.”
Usual care or management of patients on VKA therapy includes frequent visits to the hospital or general practitioner for PT/INR testing with a venipuncture and waiting up to 2-3 days for the lab results. The CoaguChek INRange system engages patients in their care with a simple fingerstick and 60-second test, giving patients the independence to continue their normal daily activities and quality of life while maintaining connections with their HCPs.
"In a clinical environment, we need to establish a model of care that empowers patients, helping them to understand their health condition and allowing them to take responsibility of their own health care needs,” stated Juan Carlos Souto, renowned Physician at the Hospital de Sant Pau in Barcelona, Spain and author of over 400 scientific articles and communications. “The new technology will enable us to access the test results in the clinic’s database, to keep track of the individual patient’s status and to measure the quality of care provided by our clinic."
Senseonics Holdings, Inc announced it has received CE Mark approval for the Eversense Continuous Glucose Monitoring (CGM) System.
“The CE Mark approval is a significant accomplishment for Senseonics as this application required rigorous regulatory review against high clinical and safety standards,” said Dr. Tim Goodnow, CEO and President of Senseonics. “The approval enables the company to market and sell the Eversense System in European Union (EU) member countries, and we are prepared to make this important medical device available to people with diabetes.”
The Eversense System includes an implanted glucose sensor that lasts up to 90 days, a wearable and removable smart transmitter to calculate glucose levels, and a mobile app for display of real-time glucose readings. The Eversense System is now the world’s first long-term wear sensor, which eliminates the weekly sensor insertion required by currently marketed CGM systems. The previously presented multi-center European PRECISE pivotal trial showed strong accuracy and safety results throughout the 90 day use of the Eversense CGM System.
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.
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.
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.
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.
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.
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.
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.
Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), today announced it received CE approval of its Alpha AMS device for marketing in the European economic area. The Alpha AMS, which is the next generation of the Alpha IMS (CE marked in 2013), is designed to restore some useful vision in patients blinded by the degenerative eye condition and has been in clinical trials across Germany and the UK since 2014. The technology has an increased number of pixels (1600), giving it the most electrodes of any neuroprosthetic implant on the market, and is estimated to last several years in the body. "We are delighted by the news that our latest device has received the CE mark. We believe that being able to provide physicians access to the Alpha AMS represents a notable step forward in treatment options for their patients," said Walter-G Wrobel, Ph.D, CEO of Retina Implant AG. "We look forward to making our technology commercially available to the patient community across Europe. We would also like to thank those patients who participated in the clinical trials to date - they have been critical to the success of our research and evolution of the Alpha AMS."
St. Jude announced CE Mark approval and launch of three new Quartet™ left ventricular (LV) leads, offering additional electrode spacing options and one new lead shape. The additional spacing combinations are aimed to more effectively target the individual cardiac anatomies of patients who need support from cardiac resynchronization therapy pacemakers (CRT-P) and defibrillators (CRT-D). Studies have shown that CRT can improve the quality of life for many patients with heart failure. CRT resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. The addition of MultiPoint Pacing™ technology enables physicians to program a single Quartet LV lead to pace multiple sites on the left side of the heart, giving the clinician more choices to improve patient response to therapy and reducing the likelihood of costly and invasive lead revision through a second intervention procedure.
The newly-approved additional quadripolar lead options are used with next-generation MultiPoint Pacing technology, which enables physicians to pace multiple locations on the left side of the heart and provide physicians a new option for patients who haven’t responded to CRT. The expanded selection of quadripolar pacing leads makes the St. Jude Medical quadripolar lead portfolio the broadest on the market and allows for enhanced individualization of CRT. The new leads are designed based on the company’s first-to-market proven quadripolar LV lead technology and include additional spacing options on two new S-shape and one new double-bend lead designs.
Some of the newly approved products are also magnetic resonance (MR) – conditional, including the Quadra Assura™ CRT-D and Quadra Assura MP™ CRT-D with MultiPoint™ Pacing. Additionally, physicians will be able to quickly customize therapy using the Auto VectSelect Quartet™ Test, which is designed to automatically guide programming of the most appropriate therapy options available and streamline workflow.
St. Jude announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.
Product information could be found from this link.
After receiving CE
mark in late 2015, Parker Hannifin announced that FDA has also cleared Indego
Exoskeleton for clinic and personal use.
Indego is a robotic
exoskeleton or powered orthotic device that allows users to stand and walk and
holds great promise for affording people with paraplegia a new level of
independence. “For individuals who sustain spinal cord injuries, this is a
milestone that could have a meaningful impact on their lives,” said Tom
Williams, chairman and CEO of Parker Hannifin.
Indego system is now
available in European market, Parker Hannifin plans to offer the device in USA
market as well in a few months.
