Intact Vascular wins CE Mark for Tack blood vessel repair device
Intact Vascular said today that it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle. The Tack implant can be used in arteries ranging from 1.5 mm to 4.5 mm in diameter and unlike stents, it adapts to the diameter of the artery, according to Wayne, Penn.-based Intact Vascular. The CE Mark was supported by data from the company’s TOBA BTK clinical trial, which examined the use of the Tack de...
Source: Mass Device - January 17, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Regulatory/Clearance Vascular Wall Street Beat Intact Vascular Source Type: news

Spectranetics wins CE Mark for smaller Stellarex DCB
Spectranetics (NSDQ:SPNC) said yesterday that it won CE Mark approval in the European Union for a smaller size of its Stellarex drug-coated balloon. The Stellarex 0.014” device is designed to treat small vessels, below-the-knee disease and challenging critical limb ischemia. The larger, 0.035” device won CE Mark approval in December 2014, just before Spectranetics paid Covidien $30 million deal for the angioplasty platform following the consummation of Medtronic‘s (NYSE:MDT) $50 billion merger with Covidien. The Colorado Springs-based company filed for pre-market approval from the FDA for Stellarex earlier...
Source: Mass Device - November 22, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Regulatory/Compliance Vascular Drug-Eluting Balloons Peripheral Artery Disease Spectranetics Corp. Source Type: news

TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016. After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, featuring big-name devices for structural heart repair and peripheral artery disease at the Transcatheter Cardiovascular Therapies conference: ...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Drug-Device Combinations Drug-Eluting Balloons TCT 2016 Transcatheter Cardiovascular Therapeutics symposium (TCT) Source Type: news

Gore touts 1-year data from Japanese study of Viabahn stent graft
W.L. Gore & Associates yesterday released 1-year data from a Japanese study of its Viabahn stent graft, touting a nearly 90% primary patency rate at 12 months. Data comes from a 103-patient single-arm study which enrolled a “challenging patient population” with lesions greater than 10cm, Newark, Del.-based Gore said. “Eighty-eight percent is an extremely high primary patency for these long complex lesions with an average length of 22 cm, especially given the scrutiny of the study design: a prospective, multicenter IDE clinical study that was core lab adjudicated and reviewed by the Japanese regulatory...
Source: Mass Device - September 21, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular W.L. Gore & Associates Source Type: news

FDA approves Medtronic ’ s In.Pact Admiral DCB for in-stent restenosis
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients. The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study comparing the DCB treatment with standard percutaneous balloon angioplasty. “Prior to the FDA approval of In.Pact Admiral DCB for ISR, physicians were challenged to find a durable treatment for PAD patients, considering the complexity of the...
Source: Mass Device - September 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Medtronic Peripheral Artery Disease Source Type: news

MassDevice.com +5 | The top 5 medtech stories for August 11, 2016
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry. Get this in your inbox everyday by subscribing to our newsletters.   5. GI Dynamics looks to next year for 2nd bite at FDA apple for EndoBarrier GI Dynamics is hoping to make another run at FDA approval for its flagship EndoBarrier treatment for obesity and diabetes after its 1st try failed last ye...
Source: Mass Device - August 11, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

Spectranetics releases final 1-year results for Stellarex drug-coated balloon
Spectranetics (NSDQ:SPNC) today released the final 1-year results from the Illumenate EU RCT study comparing treatment with its Stellarex drug-coated balloon to percutaneous transluminal angioplasty, touting a 24% higher rate of primary patency with the DCB. One-year results from the 328-patient trial were presented at the Amputation Prevention Symposium in Chicago this week. “The Stellarex DCB produced outstanding results in this rigorous trial, validating its earlier first-in-human and interim Illumenate global studies. These consistent, high quality outcomes are achieved with a low dose drug balloon, making this d...
Source: Mass Device - August 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Spectranetics Corp. Source Type: news

FDA approves longer version of Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that the FDA approved a longer version of its In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won CE Mark approval in the European Union. “The expansion of In.Pact Admiral DCB to 150mm lengths demonstrates our commitment to providing meaningful technology to improve patient outcomes in a value-based healthcare environment,” peripheral unit general manager Ma...
Source: Mass Device - July 13, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Peripheral Artery Disease Source Type: news

Getinge wins expanded FDA clearance for Sterizone VP4
Getinge (PINK:GETI B) said today it won expanded FDA clearance for its Sterizone VP4 sterilizer, now cleared to sterilize colonoscopes, gastroscopes and other multi-channel flexible endoscopes of up to 4 channels and 3.5 meters in length. The Swedish medical device firm touted the win, saying that regulatory authorities are becoming more scrutinous of medical device reprocessing, particularly for colonoscopes and other complex minimally invasive surgical devices. “With the new FDA-cleared indications for use, the Sterizone VP4 Sterilizer is the only validated and cleared low-temperature sterilizer available in the ...
Source: Mass Device - July 11, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Sterilization / Calibration Getinge Source Type: news

Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months. The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA alone for treating challenging AV access cases, both in terms of primary patency and number of interventions during the study period. Results from the study were published in the Journal of Vascular Surgery, Newark, Del.-based Gore said. “Pa...
Source: Mass Device - June 28, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular W.L. Gore & Associates Source Type: news

Intact Vascular launches clinical trial of Tack system
Intact Vascular said today it launched the Tack Optimized Balloon Angioplasty III clinical trial investigating its Tack endovascular system along with Medtronic‘s (NYSE:MDT) Admiral drug-coated angioplasty balloon for treating peripheral arterial disease. The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, Wayne, Penn.-based Intact Vascular said. “The Tack endovascular system is the ideal adjunct to drug-coated balloon angioplas...
Source: Mass Device - June 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Catheters Clinical Trials Vascular Intact Vascular Source Type: news

Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S.
This article originally appeared on MassDevice.com’s sister site, Medical Design & Outsourcing. The post Nipro launches 2nd-gen guidewire, OTW balloon cath in U.S. appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - February 19, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Nipro Source Type: news

MassDevice.com +3 | The top 3 medtech stories for February 4, 2016
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.   3. Toshiba bails on non-imaging healthcare biz Toshiba said today that it’s planning to ditch or transfer all of its healthcare business that’s not a part of Toshiba Medical Systems, its imaging division, and forecast higher losses for the rest of the year. A bidding war for Toshiba M...
Source: Mass Device - February 4, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Maquet & Biotronik ink distribution deal for peripheral devices
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Medical Systems USA said today it is partnering with Biotronik to distribute the German firms peripheral vascular devices in the U.S. Maquet will distribute “a range” of Biotronik products designed to treat peripheral artery disease, including its Astron iliac self-expanding stent, Passeo percutaneous transluminal angioplasty balloon products and the line of Fortress reinforced sheaths, the companies said. “Peripheral artery disease is a serious condition that can lead to amputations. Because the global prevalence of this disease is increasing, the need ...
Source: Mass Device - February 3, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Distribution Biotronik Getinge Maquet Cardiovascular LLC Source Type: news

Medtech approvals: FDA releases December 2015 PMAs
The Food & Drug Administration today released a list of pre-market approvals granted in December 2015: Summary of PMA Originals & Supplements Approved Originals: 2 Supplements: 81 Summary of PMA Originals Under Review Total Under Review: 58 Total Active: 32 Total On Hold: 26 Summary of PMA Supplements Under Review Total Under Review: 599 Total Active: 423 Total On Hold: 176 Summary of All PMA Submissions Originals: 3 Supplements: 92 Summary of PMA Supplement PMA Approval/Denial Decision Times Number of Approvals: 81 Number of Denials: 0 Average Days Fr Receipt to Decision (Total Time): 163.1 FDA Time: 140....
Source: Mass Device - February 2, 2016 Category: Medical Equipment Authors: MassDevice Tags: Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news