SurModics (NSDQ:SRDX) said today it won both FDA 510(k) clearance and CE Mark clearance in the European Union for its 0.014″ low-profile percutaneous translumioal angioplasty balloon dilation catheter with plans to launch the device in the coming months. The newly launched PTA ballon catheter comes equipped with the company’s Serene hydrophilic coating, allowing for low friction […]
Vascular
AlloSource touts completion of bioengineered blood vessels for Humacyte trial
Tissue-provider AlloSource said this week it completed production of investigational bioengineered blood vessels designed for Humacyte‘s Phase III clinical trial exploring the use of the vessels to improve vascular access for hemodialysis patients with end-stage renal failure. The trail aims to compare the efficacy of the bioengineered human-tissue vessels to current synthetic vessels made from […]
Endologix touts Japanese collab dev & distro deal, 1st-in-human Ovation Alto trial data
Endologix (NSDQ:ELGX) this week announced a joint R&D and exclusive distribution deal with Japan Lifeline and released case review results from the 1st-in-human use of its Ovation Alto stent graft designed for endovascular aneurysm repair. The Irvine, Calif.-based company said it inked a deal with Japan Lifeline to jointly invest in development, clinical research and commercialization […]
Medtronic touts 5-year gendered sub-analysis data from Endurant AAA stent graft trial
Medtronic (NYSE:MDT) today released new 5-year data from a gender separated subset of the Engage trial of its Endurant II abdominal aortic aneurysm stent graft system. The subset analysis aimed to compare results across both male and female patients. Fridley, Minn.-based Medtronic said that historically, women have had worse EVAR outcomes than men due to anatomy […]
PQ Bypass touts subset analysis data from Detour system trial
PQ Bypass today released subset analysis results from the Detour 1 clinical trial of its Detour system designed to treat long-segment blockages in the femoropopliteal artery, touting a 2% rate of major adverse events and no deaths or amputations at 30 days. The data was presented today at the Vascular InterVentional Advances conference, the Sunnyvale, Calif.-based […]
VIVA 17 Round-up: Medtronic touts real-world data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Get the full story at our sister site, Drug Delivery Business News.
Neovasc shares rise on Tiara transcath mitral valve trial update
Neovasc (NSDQ:NVCN) today updated on the clincial study of its Tiara self-expanding transcatheter mitral valve bioprosthesis designed to treat mitral regurgitation, touting 31 successful implants and a 12.1% rate of 30-day mortality. The Vancouver-based company said that to date 34 patients have been treated with the Tiara at 10 centers globally, with a technical implantation success […]
Gecko Biomedical wins CE Mark for Setalum vascular sealant
Gecko Biomedical said today it won CE Mark approval in the European Union for its Setalum Sealant designed for use during vascular surgery. The Paris-based company said Setalum is a biocompatible, bioresorbable sealant designed as an add-on to sutures, and is usable in wet and dynamic environments and activated using a light activation pen. The […]
Veniti inks distro deal with Boston Scientific for Vici venous stent
Veniti said today it inked a limited global distribution deal with Boston Scientific (NYSE:BSX) for its Vici venous stent. The companies did not release details on which regions Boston Scientific would distribute the stent in or any financial terms of the deal. “The Vici venous stent is widely recognized as state-of-the-art technology for venous stents and physicians […]
Abbott halts global sales of 1st-gen Absorb stents
UPDATE: Updated to include statements from Abbott Abbott (NYSE:ABT) said today it will halt global sales of its 1st-generation Absorb bioresorbable vascular scaffold due to low commercial sales. In a statement on its website, the company said it is discontinuing all sizes of the Absorb bioresorbable vascular scaffold system, effective Sept. 14. “Absorb sales accounted for […]
Japan approves Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that its In.Pact Admiral drug-coated balloon won approval from the Japanese Ministry of Health, Labour and Welfar for the treatment of peripheral artery disease in the upper leg. Before the medtech giant can begin commercialization of its drug-device combination product, it must gain reimbursement from the Japanese regulatory body, Medtronic said. “The […]