Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience. The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly […]
Stents
How suppliers are taking drug-delivery tech to the next level
Medical device industry suppliers and outsourcers are helping to enable the latest drug-delivery tech. Drug-eluting technologies are moving beyond stents, thanks in part to the development of polymeric hydrogels engineered to respond to a range of different physical and chemical stimuli. Medtech innovators have figured out how to use hydrogels as components of micro-shells or […]
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 […]
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 […]
Medtronic touts early vessel healing in independent 1-month Resolute Onyx DES trial
Medtronic (NYSE:MDT) today released data from an independent study of its Resolute Onyx drug-eluting stent, touting strong early vessel healing at one month in a patient population with a high percentage of patients with complex coronary artery disease. Data from the study was presented at the EuroPCR Annual Meeting in Paris, the Fridley, Minn.-based company said. […]
MIT study reveals the problem with bioresorbable stents
Bioresorbable coronary scaffolds, designed to avoid the risks associated with the long-term implantation of metal stents, once captured the attention of medtech giants like Abbott (NYSE:ABT) and Boston Scientific (NYSE:BSX). But companies have since linked the use of these biodegradable polymer-based devices to a heightened risk of myocardial infarction and thrombosis, prompting Abbott to pull its Absorb […]
India’s NPPA cuts prices on drug-eluting stents by nearly 8%
India’s National Pharmaceutical Pricing Authority cut prices on stents yet again, dropping the cost of certain stents by about 7.6%, according to a Reuters report. This time, the prices on drug releasing stents were cut from approximately $469.60 (INR ₹30,180) to $433.82 (INR ₹27,890), according to the report. The new price cap comes as somewhat […]
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 […]
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 […]
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. In the 268-patient group treated with Orsiro, 60-month data from […]
