Medtronic Offers Resolute Integrity Drug-Eluting Stent for Coronary Disease
U.S. Food and Drug Administration (FDA) approved Medtronic's Resolute Integrity zotarolimus-eluting stent for the treatment of coronary artery disease (CAD), including those with diabetes.
The Resolute Integrity DES builds on the success of the Integrity bare metal stent. The Integrity platform’s rapid adoption in the United States is the result of a proprietary engineering advance called continuous sinusoid technology (CST). CST 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, making each stent comparable to a flexible spring.
The approval was based on the global RESOLUTE clinical program, a large randomized controlled trial and a series of confirmatory single-arm studies involving nearly 250 sites in 32 countries. In total, the program enrolled more than 5,100 patients who received a Resolute DES; about a third (1,535) of these patients had diabetes, a proportion that mirrors the United States patient mix. RESOLUTE US enrolled 1,402 patients across 128 United States-based clinical trial sites.
At one year of follow-up in RESOLUTE US, the results included low rates of target lesion failure (TLF, 4.7 percent), clinically-driven target lesion revascularization (TLR, 2.8 percent) and definite/probable stent thrombosis (def/prob ST, 0.1 percent). These results were achieved despite 34 percent of the patients in the study having diabetes, which typically drives higher event rates.
One year of follow-up in a pre-specified analysis of patients with diabetes who received a Resolute DES as participants in the Resolute clinical program also demonstrated low rates of TLF (6.6 percent), TLR (3.4 percent) and def/prob ST (0.3 percent).
In two separate large randomized controlled trials, the Resolute DES matched the safety and effectiveness of Abbott Laboratories’ Xience V DES, which represents the market-leading DES platform in the United States.
For more information: www.medtronic.com