www.fdanews.com/articles/181591-fda-grants-clearance-to-medtronics-resolute-onyx-drug-eluting-stent
FDA Grants Clearance to Medtronic’s Resolute Onyx Drug-Eluting Stent
May 2, 2017
Dublin–based Medtronic has received FDA approval for its Resolute Onyx drug-eluting stent (DES).
The device is designed with the transradial approach (through the wrist) including 5 Fr catheter compatibility with stent sizes up to 5.0 mm. The Resolute Onyx DES helps expand treatment options for patients with extra-large vessels.
The device uses the BioLinx polymer, a hydrophilic and hydrophobic blend, allowing rapid endothelial healing with minimal inflammation and low risk of stent thrombosis.
Sizes 4.5 mm and 5.0 mm DES are available in the U.S. — Cynthia Jessup