Medtronic (NYSE:MDT) announced today that it received CE Mark approval for a one-month indication for high bleeding risk (HBR) patients implanted with the Resolute Onyx.
The medtech giant’s indication is for one-month dual antiplatelet therapy (DAPT) in HBR patients implanted with the Resolute Onyx drug-eluting stent (DES). In a news release, the company touted the indication as the first of its kind, allowing physicians to recommend a shorter regimen of DAPT after a percutaneous coronary intervention (PCI) with Resolute Onyx.
According to the release, Resolute Onyx is not currently indicated for HBR patients with one-month DAPT in the U.S., but data has been submitted to the FDA in an effort to obtain the indication. Medtronic said European approval followed its Onyx ONE global study, a one-month DAPT trial comparing Resolute Onyx to the Biosensors International (PINK:BSNRY) BioFreedom DCS.
Medtronic launched the 2,000-patient study in August 2017 and, presenting at the annual Transcatheter Cardiovascular Technologies conference in San Francisco in September 2019, announced results that showed the device to be non-inferior to its competitor.
“The use of DAPT for DES is a challenge for HBR patients who may not be able to safely tolerate the same therapy duration as recommended for the broader patient population,” Montefiore Medical Center (New York) section head of interventional cardiology & medical director of structural heart interventions Dr. Azeem Latib said in the release. “Through the Onyx ONE global clinical program, we have observed that Resolute Onyx DES with one-month of DAPT in these complex patients is safe and effective. This indication will further substantiate the option for shorter DAPT regimens, if individual patient needs demand it.”
Along with the Onyx ONE global study, Medtronic has conducted the Onyx ONE clear study in the U.S. and Japan, comprising its Onyx ONE-month DAPT program that has enrolled approximately 2,700 patients across up to 130 sites worldwide.
To date, the company has studied more than 22,000 patients in its sponsored and funded clinical trials addressing DAPT duration.
“The growing body of clinical evidence supports the use of Resolute Onyx to meet the needs of complex patient populations,” Medtronic VP and GM of the coronary and renal denervation business Dave Moeller said. “Resolute Onyx has shown exceptional outcomes in complex patient populations and anatomies, including those at a high risk of bleeding, which has helped pave the way for this first-of-its-kind approval.”