Medtronic today said it received FDA clearance for an expanded indication of its Resolute Onyx drug-eluting stent (DES).
The new indication allows for one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk patients that are implanted with the device. Resolute Onyx is the only DES in the U.S. that has been proven safe and effective using a one-month regimen of DAPT.
Clinical studies of the Resolute Onyx DES and its biocompatible polymer and stent design help promote fast vessel healing and are well-suited for patients who may benefit from DAPT duration in as short as one month, according to the company.
“It is so rewarding to see the efforts of those involved in examining the safety and efficacy of one-month of DAPT following PCI – the coordinators, investigators and most importantly the Onyx One Clear patient-participants – come to fruition with this new high bleeding risk indication for the Resolute Onyx drug-eluting stent,” the principal investigator on the Onyx One Clear Study Ajay Kirtane said in a news release. “It is remarkable how the combination of technology innovation, in conjunction with the generation of clinical evidence, has informed our understanding that shorter durations of DAPT may in fact be safe in appropriately selected patients treated with Resolute Onyx DES.”
The Resolute Onyx first received CE mark approval in April for a one-month DAPT indication for patients at high bleeding risk.
“The journey leading to an HBR indication has included years of rigorous clinical evaluation with more than 22,000 complex patients studied,” Dave Moeller, VP and GM of coronary and renal denervation at Medtronic, said. “We’re excited to realize our goal of providing physicians with more robust data and a supporting indication to inform treatment decisions for HBR patients, who may be suitable for a one-month course of DAPT.”
