The FDA has approved Medtronic’s two-millimeter Resolute Onyx drug-eluting stent (DES), making it the smallest DES on the U.S. market.
Medtronic announced the approval Feb. 26, saying the stent will allow interventional cardiologists to treat smaller vessels during percutaneous coronary intervention (PCI). The smallest DES previously available was 2.25 mm in diameter.
"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 in La Jolla, California, said in a press 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."
Price was the national principal investigator of the RESOLUTE ONYX 2.0 mm Clinical Study, which was published in JACC: Cardiovascular Interventions in July 2017 and supported the FDA approval.
In that trial, the Resolute Onyx stents proved to be “a feasible option” for treating lesions with reference vessel diameter (RVD) between 2 and 2.25 mm, the researchers reported. The rate of target lesion failure was 5 percent at 12 months, there were no episodes of stent thrombosis and target lesion revascularization and target vessel MI were 2 and 3 percent, respectively.
The smaller stent joins 4.5- and 5.0 mm stents in the Resolute Onyx lineup, which now has the broadest range of sizes of any DES family, according to Medtronic.