Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion. The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said. “This expanded indication will allow physicians the option to treat […]
Biotronik wins FDA nod for Orsiro DES
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 […]
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 […]
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