Abbott announced today that the FDA approved its Espirit everolimus-eluting resorbable scaffold system. The Espirit scaffold treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. Abbott says that before … [Read more...] about Abbott wins FDA approval for dissolving drug-eluting scaffold
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 … [Read more...] about Cook Medical wins DOD contract for drug-eluting stents
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 … [Read more...] about Getinge wins European approval for covered stent system
Getinge, Cook Medical sign U.S. commercial distribution agreement for iCast covered stent
Getinge and Cook Medical today announced they signed a commercial distribution agreement for the iCast covered stent system in the U.S. In this deal, Cook Medical will take over sales, marketing, and distribution rights for the product in the U.S. The iCast covered stent system will continue to be manufactured by Atrium Medical, a Getinge … [Read more...] about Getinge, Cook Medical sign U.S. commercial distribution agreement for iCast covered stent
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 … [Read more...] about SafeGuard Surgical wins FDA breakthrough nod for biodegradable stent backed by NFL QB
Silk Road Medical launches new transcarotid stent in the U.S.
Silk Road Medical (Nasdaq:SILK) announced today that it launched its tapered EnRoute transcarotid stent system in the U.S. Sunnyvale, California-based Silk Road says this expands upon the prior launch of its EnRoute system by adding additional configurations. It better tailors the transcarotid artery revascularization (TCAR) procedure to the … [Read more...] about Silk Road Medical launches new transcarotid stent in the U.S.
BD initiates IDE trial of stent for treating peripheral arterial disease
BD (NYSE: BDX) 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, … [Read more...] about BD initiates IDE trial of stent for treating peripheral arterial disease
Medtronic enrolls first patient in aneurysm repair trial
Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] announced today that it 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 … [Read more...] about Medtronic enrolls first patient in aneurysm repair trial
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 … [Read more...] about FDA approves Gore low-profile balloon-expandable endoprosthesis
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 … [Read more...] about Olympus completes acquisition of GI stent maker Taewoong Medical
