Endospan today announced the presentation of 30-day results from a study evaluating its Nexus aortic arch stent graft system. Results came out of the statistical dissection primary arm from the TRIOMPHE FDA investigational device exemption (IDE) study. Investigators presented findings at the American Association for Thoracic Surgery (AATS) Annual Meeting in Seattle. TRIOMPHE evaluates the […]
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Endospan completes enrollment in aortic arch stent graft study
Endospan announced today that it completed enrollment for the primary arm of its TRIOMPHE FDA investigational device exemption (IDE) trial. TRIOMPHE evaluates the safety and efficacy of the Nexus aortic arch stent graft for the treatment of aortic arch disease. The company previously said it expected to enroll up to 110 patients with a variety […]
Artivion provides $25M loan to Endospan for stent graft system
Endospan announced today that entered into an agreement with Artivion for additional loans totaling up to $25 million. Artivion develops, markets and sells a number of products in more than 100 countries around the world. Its offerings land within four groups: aortic stent grafts, surgical sealants, mechanical heart valves and implantable cardiac and vascular human […]
15 heart devices that could boost their manufacturers’ sales
Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
Endospan aortic arch stent graft wins FDA breakthrough designation
Endospan this week said its Nexus aortic arch stent graft system received FDA breakthrough device designation. The Nexus Stent Graft System allows for a minimally invasive approach to aortic arch repair, including aneurysms and dissections. “Receiving the breakthrough device designation from FDA acknowledges our novel technology has the potential to provide a unique and innovative […]
CryoLife, EndoSpan ink distribution deal
CryoLife Inc. (NYSE:CRY) today announced that it has signed a strategic distribution and credit facility agreement with Endospan with an option to purchase the company. Kennesaw, Georgia-based CryoLife will have exclusive distribution rights to Endospan’s Nexus stent graft system in Europe. CryoLife will pay $10 million upfront and provide up to $15 million in debt financing […]
7 medtech stories we missed this week: March 23, 2018
From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]
Invuity prez & CEO Sawyer steps down, Flora in as interim | Personnel Moves – March 13, 2018
Invuity (NSDQ:IVTY) said late last week that its president and chief executive officer Philip Sawyer has resigned and will be replaced by board member Scott Flora on an interim basis. Flora has served as a member of the board since last November, and has held positions as prez, CEO and director of Omniguide. He has also held […]
