Distinguished by Superior Deliverability and Diabetes Indication, New Heart Device Becomes Available to Cath Labs Nationwide

MINNEAPOLIS –– Advancing the clinical practice of interventional cardiovascular medicine, Medtronic Inc. today announced U.S. Food and Drug Administration (FDA) approval of the Resolute Integrity™ Drug-Eluting Stent (DES) for the treatment of coronary artery disease (CAD).

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 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,” explained Martin B. Leon, M.D., director of the center for interventional vascular therapy at New York-Presbyterian/Columbia University Medical Center, founder and chairman emeritus of the Cardiovascular Research Foundation, and a principal investigator (PI) of the RESOLUTE US clinical study. “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.” 

Source: Medtronic Inc.