Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant. Get the full story at our sister […]
Drug-Eluting Stents
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus 5.9% for the […]
Reva wins CE Mark for bioresorbable scaffold in below-the-knee PAD
Reva Medical (ASX:RVA) said yesterday it won CE Mark approval in the European Union for its Motiv bioresorbable drug-eluting scaffold, now cleared for treatment of below-the-knee peripheral artery disease. The San Diego-based company’s Motiv is made from the company’s proprietary radiopaque Tyrocore polymer designed for vascular scaffolds. Reva said that over the coming months, it will […]
EuroPCR 2018: Study compares drug-coated balloons in patients with arterial in-stent restenosis
At this year’s annual EuroPCR meeting, Boston Scientific (NYSE:BSXtouted results from the first trial to compare two drug-coated balloons with different drug formulations – Boston Scientific’s Agent paclitaxel-coated PTCA device and B. Braun’s SeQuent Please balloon. The 125-patient study evaluated the balloons in patients with in-stent restenosis of a lesion previously treated with a drug-eluting stent or drug-coated balloon. […]
Reva Medical swings to black on first sales
Reva Medical (ASX:RVA) this week reported its first quarterly and annual revenues since winning CE Mark approval for its bioresorbable coronary scaffolds, swinging from red to black for the full year. Get the full story on our sister site, Drug Delivery Business News.
Cordis, Medinol tout first commercial implants of Elunir drug-eluting stent in U.S.
Cordis and Medinol announced today that the first commercial uses of the Elunir drug-eluting stent in the U.S. were performed at New York-Presbyterian Hospital/Columbia University Medical Center and the Piedmont Heart Institute in Atlanta. The Elunir stent, developed by Medinol and distributed by Cordis, features a metallic spring tip and the narrowest strut width of any stent on […]
Cordis, Medinol win FDA nod for Elunir drug-eluting stent
Cordis and Medinol announced today that the FDA approved its Elunir drug-eluting stent for the treatment of patients with narrowing or blocked coronary arteries. The stent, designed by Medinol and distributed exclusively by Cordis in the U.S., features a novel metallic spring tip and the narrowest strut width of any stent on the market in the U.S., according […]
India signals shift on stent pricing cap
India’s National Pharmaceutical Pricing Authority is slated to revisit its decision to impose price caps on coronary stents in February of 2018 and it is looking for input from manufacturers, the agency said in a statement last week. The NPPA capped prices for drug-eluting stents and bioresorbable scaffolds in February this year, while also cutting […]
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 […]
Price caps to keep Abbott’s Xience Sierra off the Indian market
Abbott (NYSE:ABT) reportedly won’t introduce its next-generation drug-eluting stent, the Xience Sierra, to the Indian market due to price caps there. The everolimus-eluting coronary stent, which won CE Mark approval in the European Union this week, is designed to allow cardiologists to treat the complex lesions that make up roughly 70% of cases. It offers […]
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 […]