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FDA approves DES for treatment of CAD patients
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Medtronic today announced FDA approval of the Resolute Integrity drug-eluting stent for the treatment of coronary artery disease, which is also the first stent approved for CAD patients with diabetes.
The agency’s approval was based on results from the global RESOLUTE clinical program, consisting of a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. The program enrolled more than 5,100 patients who received the DES — about one-third of whom had diabetes.
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The RESOLUTE US program enrolled 1,402 patients (34% with diabetes) from 128 US-based clinical trial sites. At 1 year follow-up, researchers found low rates of target lesion failure (4.7%), clinically driven target lesion revascularization (2.8%) and definite/probable stent thrombosis (0.1%). A prespecified analysis of patients with diabetes who received the Resolute DES at 1 year also showed low rates of target lesion failure (6.6%), target lesion revascularization (3.4%) and definite/probable stent thrombosis (0.3%). Further, the Resolute DES matched the safety and efficacy of the Xience V DES (Abbott) in two separate large randomized, controlled trials.
Additionally, 1- and 2-year data from the Resolute All-Comers study, which enrolled nearly 2,300 patients at 17 centers, were published in The New England Journal of Medicine and The Lancet, respectively.
Similar to Medtronic’s Integrity bare metal stent, the Resolute Integrity DES uses continuous sinusoid technology, which encompasses one continuous single strand of wire that is molded into a sinusoidal wave and then wrapped in a helical pattern and laser-fused at certain points.
“The Resolute Integrity DES offers several notable benefits, starting with outstanding deliverability, which means it’s exceptionally easy to navigate the stent on the delivery system through the coronary vasculature to the narrowed arterial segment that requires treatment,” Martin B. Leon, MD, director of the center for interventional vascular therapy at New York-Presbyterian/Columbia University Medical Center and principal investigator of the RESOLUTE US clinical study, said in a press release. “Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients. With the device’s compelling combination of deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide.”
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