Vascular graft developer Somahlution said today it launched the DuraGraft European Registry clinical trial of its DuraGraft device, enrolling the 1st patient in the study. In the registry study, investigators will evaluate the Jupiter, Fla.-based company’s DuraGraft, a vascular graft treatment designed to reduce the burden of ischemia reperfusion injuries, during use in coronary artery bypass […]
Endoscopic
Gore wins Japanese regulatory nod for Gore Excluder IBE
W.L. Gore & Associates said today it won Japanese regulatory approval for its Gore Excluder iliac branch endoprosthesis and that the 1st implants of the device had been performed in the region. The Newark, Del.-based company said that the Excluder IBE was the 1st off-the-shelf iliac branch solution approved in the country, and the only device […]
Endologix dives on 2-year setback for Nellix stent graft
Endologix (NSDQ:ELGX) shares were off more than 30% this morning after the company yesterday revealed a 2-year setback for its Nellix stent graft for repairing abdominal aortic aneurysms. Irvine, Calif.-based Endologix said meetings with the FDA and “further internal analysis” led it to decide to launch a “confirmatory” trial for Nellix, which was initially delayed last November when […]
Medrobotics wins colorectal indication for Flex robot-assisted surgery system
Medrobotics said today that it won 510(k) clearance from the FDA for a colorectal procedure indication for its Flex robot-assisted surgery platform. The Raynham, Mass.-based company won expanded CE Mark approval in the European Union last October for Flex for performing colorectal procedures. The system won 510(k) clearance from the FDA for transoral procedures in July 2015 (that indication […]
Crospon wins FDA 510(k) for next-gen Endoflip system
Endoscopic diagnostic company Crospon said today it won FDA 510(k) clearance for its next-gen Endoflip system with Flip topography module, designed to allow clinicians to assess patient motility disorders during endoscopy. The newly cleared Endoflip 2.0 system includes imaging software that displays esophageal contractility patterns in real time on a touch screen display, the Ireland-based […]
Interscope wins FDA nod for EndoRotor resection tool
Interscope said today it won FDA 510(k) clearance for its EndoRotor endoscopic resection tool designed for gastroenterology and colorectal surgery. The Worcester, Mass.-based medical device startup said that the EndoRotor is the 1st flexible microdebrider designed for use in the digestive tract to facilitate complete removal of diseased mucosa. The device performs tissue dissection, resection and […]
Medtronic touts 5-year Endurant II AAA registry data
Medtronic (NYSE:MDT) today released 5-year data from the Engage global registry study of its Endurant II abdominal aortic aneurysm stent graft, touting long-term durability and consistent outcomes with the device. Results from the study, which the company claims is the most robust post-market registry of endovascular aortic repairs to date, was presented at the 2017 […]
Trumpcare’s prospects dim, but not too dim to hit stent graft makers
The push on Capitol Hill to revive Trumpcare stalled yesterday, but not before the chatter out of Washington instigated a slide for stent graft makers’ stocks. The Affordable Care Act covers a 1-time screening for abdominal aortic aneurysms in men who smoke or smoked in the past, listing the test as an “essential health benefit.” The […]
Cook Medical warns of thrombus risk with Zenith Alpha stent graft
Cook Medical this month released an urgent safety notice warning of clot risks associated with its Zenith Alpha thoracic endovascular graft when used to treat blunt thoracic aortic injuries. The company warned of a 25% observed rate of thrombus within the graft during follow-ups to a clinical trial evaluating the use of the device for […]
Cantel Medical closes CR Kennedy endoscopy assets buy
Cantel Medical (NYSE:CMN) said today it closed its buy of endoscopy business assets from Australian distributor CR Kennedy. The assets picked up by Little Falls, N.J.-based Cantel include its Mediators-branded automated endoscope reprocessors, chemistries and procedure room products. The sale also includes a full sales and service organization from CR Kennedy, the company said. “We’re excited to […]
7 medtech stories we missed this week: March 31, 2017
This week we saw a few FDA 510(k) clearances and one of the 1st uses of a next-generation surgical robot in Asia. Here are 7 medtech stories we missed this week but thought were still worth mentioning: 1. Corindus touts first Asian use of next-generation robot Corindus Vascular Robotics announced in a March 31 press […]