FDA has approved CyPass micro stent from Alcon Laboratories.
Showing posts with label minimally invasive. Show all posts
Showing posts with label minimally invasive. Show all posts
15 August, 2016
FDA approves CyPass Micro-Stent
The CyPass® Micro-Stent is a minimally invasive device that can be implanted at the time of cataract surgery. About 20% of patients undergoing cataract surgery also have glaucoma, leading to a large number of patients who could conveniently receive combined therapy.
FDA has approved CyPass micro stent from Alcon Laboratories.
FDA has approved CyPass micro stent from Alcon Laboratories.
06 July, 2016
Avitus bone harvester receives FDA approval
Avitus Orthopaedics announced that it has launched pilot sales of its Avitus™ Bone Harvester product.
The Avitus™ Bone Harvester, which has received 510(k) clearance from the FDA as a Class II medical device, is a novel surgical instrument for harvesting autologous bone graft and bone marrow in a minimally invasive manner for use in a range of spine and orthopaedic procedures.
“We are excited for the feedback and enthusiasm we have received from surgeons piloting our technology,” said Neil Shah, CEO of Avitus. “This validates the need for a streamlined way to obtain significant volumes of cancellous autograft and bone marrow. Autograft is regarded as the gold standard bone graft material; our technology has the potential to mitigate the harvesting challenges associated with autograft and provide a cost effective solution for surgeons using this bone graft option.”
Avitus expects to receive a CE mark for the Avitus™ Bone Harvester in Europe later this year. The company has begun to build partnerships in the U.S. and Europe with distributors who see the clinical and economic benefits of an autograft harvester as a strong strategic fit in their portfolios.
Avitus will be launching a Series B financing round in Q3 to support its sales expansion in the U.S. and international markets.
Additionally, Avitus has been awarded a Small Business Innovation Research (SBIR) award from the National Science Foundation (NSF) to continue research and product development, allowing the company to expand its Avitus™ platform.
“Support from the National Science Foundation has enabled us to build an incredible team and has positioned us to expand our company’s product portfolio,” said Maxim Budyansky, Chief Technology Officer of Avitus. “We are developing a platform of products that will address a broader bone graft market with a focus on superior clinical efficacy and significant cost reductions when compared to current options. We are dedicated and excited to continue working with our key opinion leaders to innovate novel products that solve unmet clinical needs.
The Avitus™ Bone Harvester, which has received 510(k) clearance from the FDA as a Class II medical device, is a novel surgical instrument for harvesting autologous bone graft and bone marrow in a minimally invasive manner for use in a range of spine and orthopaedic procedures.
“We are excited for the feedback and enthusiasm we have received from surgeons piloting our technology,” said Neil Shah, CEO of Avitus. “This validates the need for a streamlined way to obtain significant volumes of cancellous autograft and bone marrow. Autograft is regarded as the gold standard bone graft material; our technology has the potential to mitigate the harvesting challenges associated with autograft and provide a cost effective solution for surgeons using this bone graft option.”
Avitus expects to receive a CE mark for the Avitus™ Bone Harvester in Europe later this year. The company has begun to build partnerships in the U.S. and Europe with distributors who see the clinical and economic benefits of an autograft harvester as a strong strategic fit in their portfolios.
Avitus will be launching a Series B financing round in Q3 to support its sales expansion in the U.S. and international markets.
Additionally, Avitus has been awarded a Small Business Innovation Research (SBIR) award from the National Science Foundation (NSF) to continue research and product development, allowing the company to expand its Avitus™ platform.
“Support from the National Science Foundation has enabled us to build an incredible team and has positioned us to expand our company’s product portfolio,” said Maxim Budyansky, Chief Technology Officer of Avitus. “We are developing a platform of products that will address a broader bone graft market with a focus on superior clinical efficacy and significant cost reductions when compared to current options. We are dedicated and excited to continue working with our key opinion leaders to innovate novel products that solve unmet clinical needs.
More information can be found from Avitus website by following this link.
04 July, 2016
The First Minimally Invasive Heart Failure Treatment to Restore the Left Ventricle CE Approved
BioVentrix Inc announced that it has received certification for CE marking its Revivent TC™ TransCatheter Ventricular Enhancement System. Following a myocardial infarction or heart attack, the Revivent TC™ System implants proprietary micro-anchor pairs to exclude scarred myocardium from the healthy tissue of the left ventricle (LV). The restoration of the LV to a more optimal volume and conical shape has proven to enhance cardiac performance and significantly improve a patient’s quality of life.
"The certification for CE marking is not only an important milestone for the company, but also for those who treat heart failure," said Mr. Kenneth Miller, President and Chief Executive Officer of BioVentrix. "More importantly, it transforms the spectrum of treatment by offering a minimally invasive therapeutic solution for the previously ignored ventricle. By making this critical treatment available, we are giving physicians an important additional resource that they can utilize in conjunction with existing valvular and vascular therapies, making Guideline-Directed Medical Therapy (GDMT) even more effective. Moreover, it provides access to efficacious and tolerable therapy to many frail patients who previously would have no options," continued Mr. Miller. "More than 100,000 patients will become eligible each year for this device implant," said Mr. Miller.
"Heart failure remains an epidemic worldwide and the CE marking certification validates the need for a novel therapy for heart failure patients suffering from left ventricular dysfunction," added Dr. Lon Annest, Chief Medical Officer of BioVentrix. "There is no doubt that LV volume reduction is an important therapy as it directly impacts the parameters that determine prognosis and survival, such as LV volume and ejection fraction. The impact of the Revivent TC System is achieved by transcatheter access to exclude the ischemic portion of the left ventricle from the healthy tissue," continued Dr. Annest. "This empowers heart teams in Europe, who currently have a backlog of patients, and soon, in the US, to ensure optimal clinical outcomes by minimizing the risk compared to conventional surgery," said Dr. Annest.
At 2-year follow-up, patients have made remarkable improvements in their Quality of Life by 38%. Additionally, the clinical benefit has been proven to extend life for patients with a significant reduction of LV end-systolic volume index (31%) and improvement of LV ejection fraction (23%)2. Left ventricular volume reduction is especially critical for the survival of a patient as other studies have shown that significant LV volume reduction can directly prolong a patient’s life1. The Revivent TC System is the only interventional therapy that can consistently achieve this survival benefit in heart failure patients.
"The certification for CE marking is not only an important milestone for the company, but also for those who treat heart failure," said Mr. Kenneth Miller, President and Chief Executive Officer of BioVentrix. "More importantly, it transforms the spectrum of treatment by offering a minimally invasive therapeutic solution for the previously ignored ventricle. By making this critical treatment available, we are giving physicians an important additional resource that they can utilize in conjunction with existing valvular and vascular therapies, making Guideline-Directed Medical Therapy (GDMT) even more effective. Moreover, it provides access to efficacious and tolerable therapy to many frail patients who previously would have no options," continued Mr. Miller. "More than 100,000 patients will become eligible each year for this device implant," said Mr. Miller.
"Heart failure remains an epidemic worldwide and the CE marking certification validates the need for a novel therapy for heart failure patients suffering from left ventricular dysfunction," added Dr. Lon Annest, Chief Medical Officer of BioVentrix. "There is no doubt that LV volume reduction is an important therapy as it directly impacts the parameters that determine prognosis and survival, such as LV volume and ejection fraction. The impact of the Revivent TC System is achieved by transcatheter access to exclude the ischemic portion of the left ventricle from the healthy tissue," continued Dr. Annest. "This empowers heart teams in Europe, who currently have a backlog of patients, and soon, in the US, to ensure optimal clinical outcomes by minimizing the risk compared to conventional surgery," said Dr. Annest.
At 2-year follow-up, patients have made remarkable improvements in their Quality of Life by 38%. Additionally, the clinical benefit has been proven to extend life for patients with a significant reduction of LV end-systolic volume index (31%) and improvement of LV ejection fraction (23%)2. Left ventricular volume reduction is especially critical for the survival of a patient as other studies have shown that significant LV volume reduction can directly prolong a patient’s life1. The Revivent TC System is the only interventional therapy that can consistently achieve this survival benefit in heart failure patients.
More information can be found from Bio Ventrix website.
30 June, 2016
AtriCure PRO2 left atrial appendage exclusion device CE marked
AtriCure announced that it has received CE Mark for the AtriClip PRO2 Left Atrial Appendage (LAA) Exclusion System, which offers increased functionality to occlude the LAA during minimally-invasive surgical (MIS) procedures. The device was previously launched in April 2016 with FDA 510(k) Clearance in the United States.
“We are excited to bring the AtriClip PRO2 device to the European market,” said Michael Carrel, President and CEO of AtriCure. “The US launch has been well received by our customers and we’re looking forward to the continued growth of the AtriClip franchise.”
The addition of the AtriClip PRO2 device has expanded the left atrial appendage product offerings and now provides an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. These features have improved the ease of use and time it takes to manage the left atrial appendage.
“We are excited to bring the AtriClip PRO2 device to the European market,” said Michael Carrel, President and CEO of AtriCure. “The US launch has been well received by our customers and we’re looking forward to the continued growth of the AtriClip franchise.”
The addition of the AtriClip PRO2 device has expanded the left atrial appendage product offerings and now provides an ambidextrous locking and trigger-style clip closing mechanism, handle-based active articulation levers, and a hoopless end effector. These features have improved the ease of use and time it takes to manage the left atrial appendage.
Product information can be found from AtriCure website.
20 June, 2016
Transapical access and closure device receives CE approval
Micro Interventional Devices announced that it received CE Mark approval for the Company’s first product: Permaseal™ transapical access and closure device. The Permaseal device allows surgeons to access and close the left-ventricle instantaneously, reliably and without suturing the myocardium. Permaseal is the world’s first device using compliant soft-tissue PolyCorTM anchor technology.
Permaseal was validated in the STASIS Clinical Study (Secure Transapical Access and Closure Study) conducted at five European Sites. Results indicated that Permaseal shortened operating time and hospital stay, reduced adverse events including the need for transfusion and reduced 12-month mortality and stroke rates to 0%. The technology provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including TAVR, TMVR, PFO, and other minimally invasive cardiac procedures.
“The CE Mark approval of Permaseal is a tremendous achievement for MID,” said Michael Whitman, MID’s Founder, President & CEO. “Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures. We are excited that this technology is now available to our European surgeons and their patients.”
“In the near future, PolyCor and MyoLastTM technologies will be utilized in a broad range of proprietary, catheter-based products, addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation,” added Whitman. “MID’s technology platform enables open-surgical procedures to be performed percutaneously.”
Permaseal is currently the only transapical access and closure device available for commercial use in the EU. FDA clearance to market Permaseal is pending.
Permaseal was validated in the STASIS Clinical Study (Secure Transapical Access and Closure Study) conducted at five European Sites. Results indicated that Permaseal shortened operating time and hospital stay, reduced adverse events including the need for transfusion and reduced 12-month mortality and stroke rates to 0%. The technology provides a direct, safe and simple, access and closure site for emerging complex structural heart disease procedures including TAVR, TMVR, PFO, and other minimally invasive cardiac procedures.
“The CE Mark approval of Permaseal is a tremendous achievement for MID,” said Michael Whitman, MID’s Founder, President & CEO. “Permaseal is the first in a series of products designed to replace the need for suturing in structural heart procedures. We are excited that this technology is now available to our European surgeons and their patients.”
“In the near future, PolyCor and MyoLastTM technologies will be utilized in a broad range of proprietary, catheter-based products, addressing unmet needs in tricuspid repair, mitral repair and mitral valve fixation,” added Whitman. “MID’s technology platform enables open-surgical procedures to be performed percutaneously.”
Permaseal is currently the only transapical access and closure device available for commercial use in the EU. FDA clearance to market Permaseal is pending.
Product information can be found from MID website by following this link.
08 June, 2016
Avenu Medical Receives CE Approval for the Vascular Access System
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.
More details can be found from Avenu Medical website.
11 May, 2016
FDA approves left atrial appendage MIS device from AtriCure
AtriCure 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.
“We are excited to receive FDA clearance for the AtriClip PRO2 device,” said Michael Carrel, President and CEO of AtriCure. “The AtriClip franchise is the fastest growing part of our business, and we are committed to continued innovation to help our customers meet the needs of their patients. The AtriClip PRO2 system has several advancements that make it easier to use in 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.
“The AtriClip PRO2 system provides easier placement of the proven AtriClip LAA occlusion technology,” said J. Michael Smith, MD at TriHealth Heart Institute in Cincinnati. “The new deployment system facilitates less invasive treatment of the LAA, including right chest approaches in conjunction with valve replacement and cardiac ablation procedures.”
“We are excited to receive FDA clearance for the AtriClip PRO2 device,” said Michael Carrel, President and CEO of AtriCure. “The AtriClip franchise is the fastest growing part of our business, and we are committed to continued innovation to help our customers meet the needs of their patients. The AtriClip PRO2 system has several advancements that make it easier to use in 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.
“The AtriClip PRO2 system provides easier placement of the proven AtriClip LAA occlusion technology,” said J. Michael Smith, MD at TriHealth Heart Institute in Cincinnati. “The new deployment system facilitates less invasive treatment of the LAA, including right chest approaches in conjunction with valve replacement and cardiac ablation procedures.”
Product information can be found by following this link.
26 April, 2016
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.
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.
25 April, 2016
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.
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.
21 April, 2016
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.
"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.
20 April, 2016
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.
“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.
13 April, 2016
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.
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.
08 April, 2016
Medtronic Launches NURO System for Overactive Bladder Treatment
Medtronic announced the launch of its NURO(TM) System that delivers percutaneous tibial neuromodulation (PTNM) for the treatment of overactive bladder (OAB) with symptoms of urinary urgency, urinary frequency, and urge incontinence. PTNM, a minimally invasive, periodic, office-based procedure, provides a measurable reduction in urinary frequency and/or urinary incontinence episodes following treatment without the side effects of medication.
The NURO System delivers a gentle electrical pulse to the tibial nerve via an acupuncture-like needle placed in the skin near the ankle that is attached to a neurostimulator. The therapy is administered in physician offices during weekly 30-minute sessions for 12 weeks and thereafter as prescribed by a physician. Patients are free to read or listen to music while therapy is administered. The most common side effects are temporary and include mild pain or skin inflammation at or near the stimulation site.
The NURO System delivers a gentle electrical pulse to the tibial nerve via an acupuncture-like needle placed in the skin near the ankle that is attached to a neurostimulator. The therapy is administered in physician offices during weekly 30-minute sessions for 12 weeks and thereafter as prescribed by a physician. Patients are free to read or listen to music while therapy is administered. The most common side effects are temporary and include mild pain or skin inflammation at or near the stimulation site.
Detailed info is available from Medtronic website by clicking this link.
Subscribe to:
Posts (Atom)