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DES system designed for patients with large vessels approved by FDA
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Medtronic announced the FDA approval of a new drug-eluting stent designed for patients with larger vessels and for transradial access.
The DES (Resolute Onyx) is constructed by forming a single strand of cobalt wire into a sinusoidal wave, which enables thinner struts while maintaining structural strength, according to a press release from the company.
The DES has 5F catheter compatibility with stents up to 5 mm and represents the first time stent sizes of 4.5 mm and 5 mm are available in the United States, which could benefit patients with large vessels, according to the release.
“As stent technologies continue to evolve, recent clinical studies have shown that newer technologies have not established a clinical advantage over durable polymer DES,” Cardiology Today’s Intervention Associate Medical Editor Roxana Mehran, MD, cardiologist and professor of medicine at Icahn School of Medicine at Mount Sinai, said in the release. “The Resolute Onyx DES provides physicians with additional 4.5 mm and 5 mm sizes to treat patients with large coronary anatomies, while the stent’s enhanced visibility and excellent deliverability further differentiates it from other [DES] on the market.”
Data from the RESOLUTE ONYX Core Clinical Study and the Global RESOLUTE Clinical Program supported the approval, according to the release.
The DES is also available in Europe and in other countries that recognize the CE mark.
Disclosures: Mehran reports receiving consultant fees or honoraria from Janssen Pharmaceuticals, The Medicines Company, Medscape, Osprey, Watermark Research Partners, WebMD and Wiley Blackwell Publishing Company; and research grants from AstraZeneca, Bayer Healthcare Pharmaceuticals, Eli Lilly/Daiichi Sankyo and OrbusNeich