UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for […]
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. The results […]
Biosensors International said today it enrolled the 1st patient in a pivotal US study of its BioFreedom drug-coated stent. The Singapore-based company’s Leaders Free II study is an ongoing trial examining the use of the BioFreedom DCS in patients at high bleeding risk who receive an ultra-short dual anti-platelet drug regimen of 1 per month. “We […]
Cardinal Health (NYSE:CAH) said today that its Cordis subsidiary is getting back into the drug-eluting stent game via an overseas distribution agreement with Biosensors International (PINK:BSNRY). The deal calls for Cordis to sell the BioFreedom, BioMatrix NeoFlex, BioMatrix Alpha and Chroma stents made by Biosensors in Europe, the Middle East, Australia and New Zealand. Cordis said it plans to gradually […]
The Sunnyvale, Calif.-based medical device company said it will use the proceeds from the offering of debt due Feb. 1, 2018, to shore up its balance sheet.