The US Food and Drug Administration (FDA) has approved Medtronic's Resolute Integrity Drug-Eluting Stent (DES) to treat coronary artery disease (CAD).
The FDA approval of Resolute Integrity DES is based on the results of a global series of studies involving the Resolute DES, which demonstrated positive clinical performances across a broad spectrum of patients including those with diabetes.
Resolute US clinical study principal investigator Martin Leon said the Resolute Integrity DES provides 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.
With the device’s compelling combination of deliverability, efficacy and safety, the Resolute Integrity DES promises to gain rapid acceptance in cath labs nationwide," Leon said.
The Resolute Integrity DES is designed based on the Integrity bare metal stent which utilizes a continuous sinusoid technology (CST).
CST is comprised of 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.