DUBLIN - May 1, 2017 -
Medtronic plc (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Resolute Onyx™ Drug-Eluting Stent (DES). The Resolute Onyx DES builds on the proven clinical performance and superior deliverability of the Resolute Integrity™ DES to further strengthen the gold standard safety and efficacy of DES technology.
“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES,” said Roxana Mehran, M.D., cardiologist and professor of medicine at Mount Sinai School of Medicine in New York City. “The Resolute Onyx DES provides physicians with additional 4.5 mm and 5.0 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.”