W.L. Gore & Associates yesterday released 1-year data from a Japanese study of its Viabahn stent graft, touting a nearly 90% primary patency rate at 12 months. Data comes from a 103-patient single-arm study which enrolled a “challenging patient population” with lesions greater than 10cm, Newark, Del.-based Gore said. “Eighty-eight percent is an extremely high […]
Catheters
Silk Road Medical touts Medicare coverage decision for carotid procedures
Silk Road Medical said yesterday that the Centers for Medicare & Medicaid Services granted coverage for transcarotid artery revascularization procedures, including those performed with its Enroute transcarotid neuroprotection and stent system. The TCAR procedures are now eligible for coverage for patients who are treated with FDA-approved proximal embolic protection devices and approved carotid artery stent systems […]
Potrero Medical raises $5m
Potrero Medical raised $4.8 million in a new round of equity financing, according to an SEC filing posted this week. San Francisco-based Potrero developed the Accuryn monitoring system designed to use urinary catheters as diagnostic tools. The system uses a urinary catheter to deliver real-time, actionable data on urine output, core temperature and intra-abdominal pressure, […]
Essential Medical closes $14.9M Series B for vascular closure device
Essential Medical said today that it closed a $14.9 million Series B round to support the development and commercialization of its vascular closure devices. The round was led by Amzak Health and joined by prior backer Royal DSM venture investment arm DSM Venturing, the Malvern, Pa.-based company said. “We are thrilled that Amzak Health has the […]
FDA approves Medtronic’s In.Pact Admiral DCB for in-stent restenosis
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients. The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study […]
Balt International buys Blockade Medical
European medtech firm Balt International said today it acquired endovascular device developer Blockade Medical for an undisclosed amount. The acquisition is part of Balt’s ongoing strategy to bolster its neurovascular portfolio as well as efforts to develop a presence in the U.S., the company said. “This acquisition is a first strategic move towards transforming Balt […]
FDA approves Concentric Medical’s Trevo clot retrievers
UPDATED Sept. 7, 2016, with comment from Stryker The FDA said today that it granted expanded approval to 2 of Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo clot retrieval devices, with new indications as initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities. The indications expand previous clearances for the devices, […]
FDA nod for Angel catheter triggers $3m tranche for Bio2 Medical
The 510(k) clearance Bio2 Medical won from the FDA in July for its Angel catheter triggered a 2nd, $3 million tranche from Oxford Finance last week, the company said yesterday. The Angel catheter is designed to provide access to the central venous system and to trap blood clots before they can reach the lungs, according to […]
Gore launches DrySeal Flex introducer sheath
W.L. Gore & Associates said today it is launching its DrySeal Flex introducer sheath designed for use with its Gore Excluder iliac branch endoprosthesis device, which is used for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The newly-launched device is designed with improved flexibility, kink resistance and a hydrophilic coating to […]
Vention Medical boosts footprint in Ireland
Vention Medical said today that it boosted its footprint on the Emerald Isle with the opening of a new facility on the National University of Ireland’s Galway campus. Get the full story at our sister site, Medical Design & Outsourcing.
Getinge, GE Healthcare launch ‘hybrid OR’ flexible angiography combo
Getinge (PINK:GETI B) said yesterday it launched a new combined angiography system designed for hybrid operating rooms as a collaborative project with GE Healthcare (NYSE:GE). The system combines Getinge’s Maquet brand Magnus OR table with GE’s Discovery IGS 730 angiography system to allow for an expanded range of surgical procedures and interventions. “Hybrid ORs have become the […]