Medtronic (NYSE:MDT) said today that the FDA approved its Resolute Onyx drug-eluting stent.
The Fridley, Minn.-based company touted its device as the 1st stent formed by a sinusoidal wave of cobalt alloy wire. The company incorporated a radiopaque inner core within the wire to boost visibility, according to Medtronic. The stent also features thin struts and a polymer blend that minimizes inflammation and risk of stent thrombosis.
“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES,” Dr. Roxana Mehran, cardiologist and professor of medicine at Mount Sinai School of Medicine, said in prepared remarks. “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 excellent deliverability further differentiates it from other drug-eluting stents on the market.”
The stent was designed for a transradial approach and is available in sizes up to 5.0 millimeters – the largest available in the U.S., Medtronic said.
“We set out to expand upon a proven DES technology to enhance clinical performance and deliver further meaningful innovations that address the needs of interventional cardiologists around the globe,” Jason Weidman, VP & GM of the coronary and renal denervation biz, added. “Already making a significant impact outside of the U.S., the Resolute Onyx DES with Core Wire Technology exemplifies our commitment to advancing our DES portfolio by combining cutting-edge engineering with proven components for a wide range of patients.”
The FDA’s approval was supported by data from the Resolute Onyx Core trial and long-term safety and efficacy data from the Global Resolute clinical program.
The Resolute Onyx drug-eluting stent also has CE Mark clearance in the European Union.