With Edwards and Abbott making recent waves in the tricuspid regurgitation (TR) treatment space, CroíValve hopes to pave its own way. Edwards’ Evoque valve became the first transcatheter therapy to receive FDA approval to treat TR in February. This month, Abbott became the second with its TriClip transcatheter edge-to-edge repair (TEER) system picking up an […]
Stents
Cook Medical wins DOD contract for drug-eluting stents
Cook Medical announced today that the U.S. Dept. of Defense (DOD) awarded it an ECAT contract for implantable medical devices. The contract includes implantable vascular medical devices like the Zilver PTX drug-eluting peripheral stent. It also applies to the Zenith aortic endografts and associated interventional devices for treating vascular disease. Cook Medical said in a […]
Getinge wins European approval for covered stent system
Getinge announced today that it received EU MDR certification for its Advanta V12 covered stent system for patients with aortoiliac occlusive disease (AIOD). The balloon-expandable covered stent’s indication aligns with AIOD, which includes treating lesions at the aortic bifurcation. Getinge said EU MDR certification highlights its dedication to providing safe, effective, high-quality products. With the […]
Silk Road launches next-gen transcarotid neuroprotection system
Silk Road Medical (Nasdaq:SILK) announced that it launched its EnRoute Plus transcarotid neuroprotection system. The transcarotid artery revascularization (TCAR) system builds upon the company’s previous EnRoute system, launched just last month. It delivers smoother arterial sheath insertion, greater flow precision and a simplified prep experience for surgical teams. The system delivers all this while maintaining […]
Biotronik wins FDA breakthrough nod for below-the-knee resorbable scaffold
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 […]
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 […]