Medtronic gains FDA approval of drug-eluting stent

Medical device company Medtronic has gained FDA approval of its Resolute Onyx drug-eluting stent.

The stent is manufactured by forming a single strand of cobalt alloy wire into a sinusoidal wave, a method used by Medtronic called Continuous Sinusoid Technology (CST). Medtronic claim that the Onyx Stent is the only device to feature Core Wire Technology (CWT), an evolution of CST. With CWT, Medtronic claims the Onyx stent has thinner struts alongside maintained structural strength and a radiopaque inner core to boost visibility.

The device uses polymer that features a hydrophilic and hydrophobic blend, allowing rapid endothelial healing, minimal inflammation and lower risk of stent thrombosis.

Dr. Roxana Mehran, cardiologist and professor of medicine at Mount Sinai School of Medicine said: “

“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES. 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.”

Jason Weidman, VP & GM of the coronary and renal denervation business added: “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. 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.”