Next-generation DES gains FDA approval
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Medtronic announced it received FDA approval for its next generation drug-eluting stent.
The new DES (Onyx Frontier) utilizes the same stent platform as its previous DES (Resolute Onyx), with a delivery system designed to improve deliverability and increase acute performance, according to a press release issued by the company.
Meaningful design changes over the prior generation of DES include increased catheter flexibility, dual-layer balloon technology and a lower crossing profile, conferring a 16% improvement in deliverability compared with the previous generation, according to the release.
Moreover, the new DES is the only 2 mm DES available in the U.S., similar to its predecessor, and shares the same clinical indications, including for patients at high risk for bleeding who may benefit from a dual antiplatelet therapy duration as short as 1 month, the company stated in the release.
"The new Onyx Frontier DES, with its enhanced deliverability, will continue to help interventional cardiologists treat complex coronary cases and larger ranges of vessel sizes more efficiently," Azeem Latib, MD, section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York, said in the release. "Delivering safe and effective outcomes to our patients is our number one priority. It's important that physicians have access to tools like the Onyx Frontier DES that can allow them to efficiently achieve those outcomes."
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