Medtronic announced Monday that the U.S. Food and Drug Administration has approved the Resolute Onyx 2.0 mm drug-eluting stent (DES), which the company says is now the smallest DES on the market. "Patients with lesions in small vessels or complex vasculatures can present unique challenges for physicians during (percutaneous coronary intervention) procedures," Matthew J. Price, MD, interventional cardiologist at Scripps Clinic in La Jolla, Calif., said in Medtronic’s announcement. "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." Price was national principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, which supported the recent FDA approval, according to Medtronic. The clinical study (NCT02412501), released at EuroPCR 2017 and published in JACC: Cardiovascular Interventions, enrolled 101 subjects with 104 lesions. The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively, according to the study’s results. There were no episodes of stent thrombosis, in-stent late lumen loss was 0.26±0.48 mm, and the rate of binary restenosis was 12.0%, Price and colleagues wrote. The study concluded that the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of target lesion failure and late lumen loss, without a signal for stent thrombosis. “This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels,” the authors wrote.