FDA approves Medtronic’s Resolute Onyx drug-eluting stent

The U.S. Food and Drug Administration (FDA) approved the Resolute Onyx drug-eluting stent for adults with coronary artery disease.

Medtronic, which manufactures the stent, announced the approval on May 1. The company also said it had launched the stent in 4.5 mm and 5 mm sizes, which expand the options available for patients with extra-large vessels.

The approval was based on results of the RESOLUTE ONYX Core (2.25 mm-4 mm) clinical study and the Global RESOLUTE clinical program, which showed patients receiving the stents had low stent thrombosis rates.

The Resolute Onyx is manufactured from a single strand of core wire into a sinusoidal wave, which Medtronic said enables greater deliverability and conformability to the vessel wall. The company added that the stent was designed with the transradial approach in mind and has 5 French catheter compatibility. Medtronic launched the Resolute Onyx in Europe in 2014.

“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer [drug-eluting stents],” Roxana Mehran, MD, cardiologist and professor of medicine at Mount Sinai School of Medicine in New York, said in a news release. “The Resolute Onyx DES provides physicians with additional 4.5 mm and 5 mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and exceptional deliverability further differentiates it from other drug-eluting stents on the market.”