Biotronik announced today that it won FDA breakthrough device designation for its Freesolve below-the-knee resorbable magnesium scaffold. The company designed the Freesolve BTK RMS for individuals with chronic limb-threatening ischemia (CLTI). It recently launched the scaffold in Europe after receiving CE mark for treating coronary artery lesions. Lake Oswego, Oregon-based Biotronik based its system on the […]
Stents
SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
SafeGuard Surgical announced today that the FDA granted breakthrough device designation to its LeakGuard biodegradable stent. Along with the regulatory milestone, the company announced that it completed its Series A funding round. Tom Pepin, principal at Tapper Ventures, led the financing. NFL quarterback Jameis Winston is also one of the first investors in the company. […]
BD initiates IDE trial of stent for treating peripheral arterial disease
BD announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed […]
Medtronic, Rijnstate enroll first patient in aneurysm repair trial
Medtronic , with Rijnstate, announced today that they enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal aortic aneurysm (AAA) with a wide, infrarenal neck diameter. Abdominal aortic aneurysms […]
InspireMD wins CE mark for carotid stent system
InspireMD (Nasdaq:NSPR) announced today that it received CE mark approval for its CGuard embolic prevention carotid stent system (EPS). The Tel Aviv, Israel-based company designed CGuard for the prevention of stroke. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes. InspireMD highlighted the importance of the transition to the […]
FDA approves Gore low-profile balloon-expandable endoprosthesis
W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis. FDA approval builds on the company’s proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range of stent diameter adjustability. […]
Olympus completes acquisition of GI stent maker Taewoong Medical
Olympus announced today that it closed its acquisition of Taewoong Medical, a Korea-based medical device manufacturer. Taewoong Medical develops gastrointestinal (GI) metallic stents, among other offerings. Olympus announced its intent to acquire the company for $370 million in February 2023. The deal includes $255.5 million upfront, with up to $114.5 million in potential milestone payments […]
Gore enrolls first patients in expandable stent graft trial
W.L. Gore & Associates announced today that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft. The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition. Dr. […]
Imperative Care begins first-in-human study of neurovascular stent
Imperative Care announced today that it initiated a first-in-human clinical study for its novel neurovascular stent system. Campbell, California-based Imperative Care designed the system to only require single antiplatelet therapy for patients undergoing stent-assisted treatment of wide-neck intracranial aneurysms. Dr. Nobuyuki Sakai successfully treated the first three patients enrolled in the study. Sakai serves as […]
Micro Medical Solutions completes enrollment in vascular stent study
Micro Medical Solutions announced today that it completed enrollment in a U.S. pivotal clinical study of its MicroStent system. Wilmington, Massachusetts-based Micro Medical set up its study to evaluate MicroStent’s safety and effectiveness. The study pits the stent against the current standard of care, percutaneous transluminal angioplasty (PTA). MicroStent, a vascular stent, was designed to […]
The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE […]