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 from a single strand of cobalt alloy, formed into a sinusoidal wave with a radio-opaque core, Medtronic said.
The Fridley, Minn.-based company claimed the Resolute Onyx One-Month DAPT Study as the first designed to evaluate clinical DAPT outcomes between a pair of drug-eluting stents.
“We’re continuously looking at ways to invest in clinical evidence and expand our product portfolio to help address the most important unanswered questions and unmet needs in interventional cardiology,” vice president Dr. Martin Rothman said in prepared remarks. “In addition to generating new, meaningful evidence to help guide clinical practice, we are also looking to develop next-generation technologies that will build on the exceptional deliverability that physicians have come to expect with our stent platforms. Along with DES, our pipeline includes a cadre of other tools that will help interventional cardiologists improve patient outcomes and address unmet clinical needs around the world.”
“The Zeus trial and subsequently, the Leaders-Free trial (which evaluated a different DCS vs. BMS), showed that other DES systems could be a better alternative to BMS in patients with a high risk of bleeding,” added principal investigator Dr. Stephan Windecker of the Bern University Hospital in Switzerland. “The study addresses the critical question whether newer-generation durable-polymer DES, like Resolute Onyx, that have demonstrated excellent procedural success in addition to sustained long-term safety and efficacy could potentially improve results even further among these patients.”
Medtronic won CE Mark approval for Resolute Onyx in November 2014 and added FDA approval in April. The device launched in Japan last month.
