Medtronic‘s Resolute Integrity drug eluting stent has been cleared by the FDA for treatment of coronary artery disease. The device is built on the platform of the Integrity bare metal stent that uses a wire that is specially bent and wound like a helix to create a spring-like structure.
The device was approved in Europe about a year and a half ago.
From the announcement:
The new heart device’s FDA approval stems from the results of a global series of studies involving the Resolute DES, which showed consistently powerful clinical performance across a broad spectrum of patients –– including those with diabetes, a common contributor to coronary artery disease that complicates treatment. The Resolute DES uses the same drug-and-polymer combination as the Resolute Integrity DES.
The Resolute Integrity DES builds on the success of the market-leading 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 global RESOLUTE clinical program consisted of 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 U.S. patient mix.
RESOLUTE US enrolled 1,402 patients across 128 U.S.-based clinical trial sites. It was led by Dr. Leon and his co-PIs: Laura Mauri, M.D., chief scientific officer of the Harvard Clinical Research Institute and an interventional cardiologist at Brigham and Women’s Hospital in Boston; andAlan Yeung, M.D., director of intervent ional cardiology at Stanford University School of Medicine in Palo Alto, Calif.
At one year of follow-up in RESOLUTE US, the results included low rates of target lesion failure (TLF, 4.7%), clinically-driven target lesion revascularization (TLR, 2.8%) and definite/probable stent thrombosis (def/prob ST, 0.1%). 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%), TLR (3.4%) and def/prob ST (0.3%).
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.
Press release: Medtronic Resolute Integrityâ„¢ Drug-Eluting Stent Obtains FDA Approval for Treating Coronary Artery Disease
Product page: Resolute Integrity
Flashback: Medtronic’s Resolute Integrity Now Available in Europe
