An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases […]
Medtronic wins expanded FDA indication for Resolute DES
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 […]
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