FDA approve Resolute Integrity (Medtronic Inc) Drug-Eluting Stent

The FDA has approved the Resolute Integrity Drug-Eluting Stent (DES), from Medtronic Inc, for the treatment of Coronary Artery Disease (CAD). The device�s approval stems from the results of a series of studies of the Resolute DES, which showed consistent clinical performance across a broad spectrum of patients �� including those with Diabetes, a common contributor to Coronary Artery Disease that complicates treatment. The decision was based in part on RESOLUTE US, which enrolled 1,402 patients across 128 US-based clinical trial sites and was led by Martin B. Leon, director of the center for interventional vascular therapy at New York-Presbyterian / Columbia University Medical Center. At one year of follow-up, 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. The Resolute DES uses the same drug-and-polymer combination as the Resolute Integrity DES. The Resolute Integrity uses continuous sinusoid technology (CST), based on 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. This design makes it suitable for treating Diabetic patients who may have smaller and often tortuous arteries, longer lesions, diffuse disease and a higher rate of treatment failures including relatively high rates of repeat procedures and stent thrombosis.