Development stage medical device firm Amsel Medical today touted the first-in-human clinical use of its Amsel AOD2 occluder device, which took place at the NYU Langone Medical Center in New York. The Cambridge, Mass. and Israel-based company said its AOD2 device was used during a variety of vascular surgical cases to ligate and occlude target […]
Vascular
Bellerophon Therapeutics misses EPS estimates in Q3
Shares in Bellerophon Therapeutics (NSDQ:BLPH) fell slightly today after the company missed EPS expectations on Wall Street with its third quarter results. The Warren, N.J.-based company posted a net loss of -$7.6 million for the 3 months ended Sept. 30, for bottom-line loss of -81% compared with the same period last year. Get the full story at […]
Boston Scientific recalls certain sizes of Eluvia, Innova stents
Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a documentfiled by the Federal Institute for Drugs and Medical Devices in Germany. The company said it was pulling these particular devices due to the number of complaints that […]
Mercator MedSystems to study its Bullfrog micro-infusion device in below-the-knee critical limb ischemia
Mercator MedSystems announced last week that it finished enrollment for a six-month trial of its Bullfrog micro-infusion device in patients with below-the-knee critical limb ischemia. The Emeryville, Calif.-based company’s 120-patient trial was designed to evaluate if Mercator’s Bullfrog device can improve blood flow and reduce the occurrence of restenosis following atherectomy-based revascularization. Mercator’s micro-infusion device delivers […]
TCT 2017: Drug-eluting balloon achieves non-inferiority with drug-eluting stent
Researchers studying 278 patients with in-stent restenosis found that B. Braun‘s SeQuent Please paclitaxel-eluting balloon was non-inferior to Abbott‘s (NYSE:ABT) Xience drug-eluting stent when it comes to six-month minimal lumen diameter. The study’s results were touted this week at the annual Transcatheter Cardiovascular Therapeutics conference in Denver, Colorado. Get the full story at our sister site, Drug […]
TCT 2017: Medtronic & OrbusNeich evaluate shortening dual antiplatelet therapy with drug-eluting stents
At this year’s Transcatheter Cardiovascular Therapeutics meeting, companies presented work comparing shortened durations of dual anti-platelet therapy with the standard 1-year regimen in patients treated with a drug-eluting stent. Among those companies were Medtronic (NYSE:MDT) and OrbusNeich. Here’s a look at what they found. Get the full story at our sister site, Drug Delivery Business News.
Biotronik’s Orsiro drug-eluting stent succeeds at five-year follow-up
Biotronik touted long-term safety and efficacy data for its Orsiro drug-eluting stent yesterday at this year’s Transcatheter Cardiovascular Therapeutics meeting. Data from the Bioflow-II trial and the Bioflow-III registry demonstrated that Biotroniks’s device boasts strong safety and clinical performance at five years, the company reported. Get the full story at our sister site, Drug Delivery Business […]
Here’s how Amaranth Medical plans to get ahead with its bioresorbable scaffold tech
There are two ways to make a bioresorbable, drug-eluting scaffold, according to Amaranth Medical CEO Kamal Ramzipoor. “The Amaranth way, or the conventional way, which our competition is using,” he told Drug Delivery Business News. “What we’ve seen throughout the years is the conventional method has some very significant limitations. And that’s what has manifested itself into, unfortunately, what’s going […]
Reva, Biotronik tout safety data for their drug-eluting bioresorbable scaffolds
Despite the safety concerns plaguing Abbott‘s (NYSE:ABT) Absorb device, companies developing bioresorbable scaffolds are not discouraged. This week at the annual Transcatheter Cardiovascular Therapeutics Conference in Denver, a number of companies touted the safety data coming from clinical trials of their products. Among them were Reva Medical (ASX:RVA) and Biotronik – here’s an overview of that data. Get the full story at […]
Long-term data for Abbott’s Absorb “highlight the need for continued improvements” in BRS tech
Hours before Abbott (NYSE:ABT) presented three-year data from a pivotal trial of its Absorb bioresorbable scaffold, the FDA updated a letter to healthcare providers, writing that the device continues to show an increased rate of major adverse cardiac events and thrombosis compared to patients treated with a drug-eluting stent. “The FDA’s recommendations for health care providers outlined […]
TCT 2017: OrbusNeich’s dual therapy stent non-inferior to Abbott’s Xience DES in 1-year follow-up
OrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott’s (NYSE:ABT) Xience stent in patients with ischemic heart disease. The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting stent after […]