Medtronic Gets Premarket Approval for its Onyx Frontier Drug-Eluting Stent

Medtronic has received the FDA’s premarket approval for its Onyx Frontier drug-eluting stent (DES).

The latest in the company’s Resolute DES product line, the new stent is used to treat patients with coronary artery disease and can be expanded to 6.00 millimeters to support extra-large vessels.

Design changes in the new stent include increased catheter flexibility and dual-layer balloon technology, leading to a 16 percent improvement in deliverability compared with the previous generation Resolute Onyx DES, the company said.

One researcher who has studied the product, Azeem Latib, medical director of structural heart interventions at Montefiore Medical Center in New York City, said it will “help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently.”