Medtronic‘s (NYSE:MDT) Resolute Onyx drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according to data from the Resolute Onyx 2.0mm trial.
The trial enrolled 101 patients with extra-small vessel sizes ranging from 2 millimeters to 2.25 millimeters. Patients treated with the Resolute Onyx stent had significantly lower rates of target lesion failure at 1 year compared to a pre-determined performance goal.
The target-vessel myocardial infarction rate was 3% and the target lesion revascularization rate was 2% at 1 year, with no reports of cardiac death or stent thrombosis.
“Treating coronary disease in extremely small arteries presents a real clinical challenge, as these lesions tend to be located in difficult-to-reach areas of the heart, have greater restenosis rates, and until now, we lacked the right stents to treat them safely and successfully,” principal investigator Dr. Matthew Price said in prepared remarks. “The excellent clinical performance we observed demonstrates the importance of designing stents like the Resolute Onyx DES that address a relevant unmet need. Thinner struts with enhanced radiopacity and a lower crossing profile provide excellent deliverability, and the stent can be over-expanded to treat tapered, challenging lesions.”
The Resolute Onyx drug-eluting stent is the 1st to use a single strand of cobalt alloy wire formed into a sinusoidal wave, which Medtronic said enables greater deliverability and conformability to the vessel wall. The company also incorporated a radiopaque inner core within the cobalt alloy wire to boost visibility.
“The Resolute Onyx 2.0 mm Clinical Study builds on the positive body of evidence supporting the clinical performance of the Resolute Onyx stent,” VP and GM of the coronary and renal denervation biz, Jason Weidman, added. “These initial results reinforce the unique design of the Resolute Onyx, providing physicians and patients around the globe with the gold standard in drug-eluting stents.”
Although the Resolute Onyx stent won FDA approval earlier this month, the 2.0 millimeter diameter version of the stent is for investigational use only in the U.S.
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