Medtronic‘s (NYSE:MDT) 2.0-mm Resolute Onyx drug-eluting stent has won FDA approval and is set to launch in the U.S., making it the smallest device of its kind on the market.
The stent is designed to treat patients with coronary artery disease who have small vessels. Interventional cardiologists often face challenges treating this patient group with larger, conventional stent technologies, according to Medtronic.
“Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during PCI procedures,” Dr. Matthew Price, principal investigator for Resolute Onyx’s clinical program, said in prepared remarks. “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.”
The 2.0-mm device also features the lowest crossing profile of any approved drug-eluting stent. Once it’s delivered into the patient, the Resolute Onyx stent expands from 2.0-mm to 3.25-mm.
The Resolute Onyx platform is made using Medtronic’s Core Wire tech, which involves shaping a single strand of cobalt alloy wire into a sinusoidal wave.
“Furthering our core objective of developing technologies that address unmet patient needs, the introduction of the Resolute Onyx 2.0 mm DES allows physicians to expand treatment options for patients with smaller vessels,” Dave Moeller, VP & GM of Medtronic’s coronary and renal denervation business, added. “The Resolute Onyx DES is an incredibly deliverable product that incorporates various design enhancements enabling physicians to optimize treatment for a wide range of patients.”
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