Boston Scientific (NYSE:BSX) is reportedly still considering a market withdrawal in India for its Synergy adsorbable polymer stent, after repeated attempts to lift a government-imposed price cap were rebuffed by regulators there. Representatives from the Marlborough, Mass.-based medical device giant met yesterday with National Pharmaceutical Pricing Authority officials to discuss pulling Synergy from India, according to LiveMint. […]
Micell raises $62m for MiStent SES
Micell Technologies said last week that it raised a debt-and-equity round worth nearly $62 million from a syndicate of 51 unnamed investors. Paris-based Micell makes the MiStent SES sirolimus-eluting absorbable polymer coronary stent, designed to treat coronary artery disease. The company, which reported a nearly $26 million round last November, said in a regulatory filing that the […]
Medtronic launches DAPT study for Resolute Onyx DES
Medtronic (NYSE:MDT) said today that it’s launching a study of dual anti-platelet therapy and its Resolute Onyx drug-eluting stent. The 2,000-patient study is designed to compare a one-month course of aspirin and an anti-coagulant in conjunction with the Resolute Onyx device or the BioFreedom DES made by Biosensors International (PINK:BSNRY). The Resolute Onyx stent is made […]
Reva Medical pursues direct-sales after Boston Scientific distro negotiation deal lapses
Reva Medical (ASX:RVA) said today it will take up direct marketing of its peripheral and vascular scaffolds after Boston Scientific‘s (NYSE:BSX) right to negotiate for exclusive distribution of the products expired. San Diego, Calif.-based Reva said that Boston Scientific had gained the right to negotiate for exclusive distribution rights under a 2007 agreement which would have positioned […]
Boston Scientific to end Renuvia bioresorbable coronary stent program
Boston Scientific (NYSE:BSX) is looking to terminate its Renuvia bioresorbable coronary stent program, according to a Minneapolis Star Tribune report. The move comes after new clinical studies of Abbott‘s (NYSE:ABT) Absorb bioresorbable stent indicated that use of the device resulted in a higher risk of serious adverse events compared to metal stents. Marlborough, Mass.-based Boston Scientific said that while the […]
Amaranth Medical looks to recapture the potential of bioresorbable scaffolds
Dr. Antonio Colombo had finished his presentation of 9-month data for Amaranth Medical‘s Aptitude sirolimus-eluting bioresorbable scaffold when an audience member asked about adverse events. He told the EuroPCR attendee that they hadn’t seen any adverse events related to the device during the trial – and that’s unusual. Bioresorbable scaffolds, like Abbott‘s (NYSE:ABT) Absorb, have been […]
Medtronic wins FDA nod for Resolute Onyx drug-eluting stent
Medtronic (NYSE:MDT) said today that the FDA approved its Resolute Onyx drug-eluting stent. The Fridley, Minn.-based company touted its device as the 1st stent formed by a sinusoidal wave of cobalt alloy wire. The company incorporated a radiopaque inner core within the wire to boost visibility, according to Medtronic. The stent also features thin struts and a polymer […]
Stable blood sugar linked to heart stent outcomes
Patients with type 2 diabetes and a coronary stent are at lower risk for heart attack and stroke if they maintain good blood sugar control, according to a recent study. “Although intensive glucose control had no benefit on the rate of major cardiovascular events in previous studies, our data suggest that strict glucose control after […]
How Boston Sci is getting drug-eluting stents and balloons into legs
Boston Scientific officials think they have a leg up when it comes to bringing drug-eluting technology to bear on peripheral artery disease. That’s because the medical device giant has decades of experience with balloons and drug-eluting stents used around the heart. When it comes to treating the narrowing arteries in the legs and thighs, Boston […]
Abbott to restrict Absorb bioresorbable stent in Europe
Abbott (NYSE:ABT) plans to restrict the use of its Absorb bioresorbable stent in Europe after a clinical study found a higher risk of serious adverse events. In a March 31 letter to physicians (posted online April 5 by a prominent cardiologist from Atlanta), Abbott said it would restrict use of the Absorb and Absorb GT1 devices to […]
Drug Delivery Business News
@DrugDeliveryNow
LinkedIn