February 26, 2018
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DES approved for use in small coronary vessels

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Medtronic announced that its drug-eluting stent designed for use in small vessels received FDA approval and has been launched in the United States.

The zotarolimus-eluting stent (Resolute Onyx 2.0 mm) was approved for treatment in patients with CAD who have small vessels, who are often unable to be treated with conventional stent sizes when undergoing PCI, according to a press release issued by the company.

Approval was supported by the results of the RESOLUTE ONYX 2.0 trial, presented at EuroPCR in May 2017 and simultaneously published in the JACC: Cardiovascular Interventions, according to the release.

The device has the lowest crossing profile of any available DES, and once delivered, it can expand from 2 mm to 3.25 mm, the company stated in the release.

“Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures,” Matthew J. Price, MD, interventional cardiologist at Scripps Clinic and a member of the Cardiology Today’s Intervention Editorial Board, said in the release. “The Resolute Onyx 2.0 mm DES is an extremely deliverable stent that, when needed, can be post-dilated to 3.25 mm to treat lesions in difficult-to-reach areas of the heart.”

References:

Price MJ, et al. PCI – Procedural techniques and clinical outcomes: Session comprising selected EuroPCR 2017 late-breaking trial submissions. Presented at: EuroPCR; May 16-19, 2017; Paris.

Price MJ, et al. JACC Cardiovasc Interv. 2017;doi:10.1016/j.jcin.2017.005.014.

 

Disclosures: The RESOLUTE ONYX 2.0 study was funded by Medtronic. Price reports receiving consultant fees from Boston Scientific and Medtronic and speaker fees from Abbott Vascular and Medtronic.