Creative Medical Technology Holdings (OTC:CELZ) touted its exosome technology today, reporting that it demonstrated an ability to regenerate healthy brain cells while selectively halting the growth of glioma brain cancer cells in a preclinical model. The company’s exosomes are vesicles harvested from amniotic stem cell technology, which it licensed from the University of California San Diego in an […]
Stent Grafts
Gore touts 1st commercial use of Tag thoracic stent graft
W.L. Gore & Associates said today its Tag conformable thoracic stent graft was used in its 1st commercial procedure after the system won CE Mark approval in the European Union last month. The procedure was performed by Dr. Giovanni Torsello and Dr. Martin Austermann of Munster, Germany’s St. Franziskus Hospital, the Flagstaff, Ariz.-based company said. “The enhanced […]
U.S. legislators ask India to reconsider stent price caps
(Reuters) – A group of U.S. lawmakers has backed medical device makers by urging India to reconsider its decision to cap prices of heart stents, raising the issue ahead of Prime Minister Narendra Modi’s visit to the United States later this week. In a letter sent to the Indian ambassador to Washington last month, and […]
Endologix touts low rate of endoleaks, mortality in 2-year Nellix study results
Endologix (NSDQ:ELGX) today announced the presentation of 2-year data from the EVAS Forward IDE trial of its Nellix stent graft for repairing abdominal aortic aneurysms, touting a high rate of freedom from endoleaks, ruptures and mortalities. Results from the trial were presented by study principal investigator Dr. Jeffrey Carpenter of New Jersey’s Cooper Medical Schoo and […]
Vascular graft dev Somahlution launches EU registry trial of DuraGraft
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 […]
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 […]
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 […]
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 […]