Advancing the clinical practice of interventional cardiovascular medicine, India Medtronic today announces the availability of the U.S. Food and Drug Administration (FDA) approved Resolute Integrity™ Drug-Eluting Stent (DES) for the treatment of coronary artery disease (CAD) in India.
Speaking to the Media, India Medtronic’s Managing Director & Vice President-South Asia – Milind Shah said “The device combines deliverability, efficacy and safety, not to mention that it is the first DES approved for patients with diabetes. With India having the second highest Diabetic population in the world, the Resolute Integrity coronary stent is set to gain wide acceptance in the country. Medtronic looks forward to providing the benefits to the patients here.”
Its approval by the FDA is based on the impressive performance of the Resolute DES in a wide variety of patients. 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. 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 nationwide.
The Resolute Integrity DES builds on the success of the market-leading Integrity bare metal stent. The Integrity platform’s rapid adoption 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.
With the Resolute Integrity DES, patients with both CAD and diabetes now have access in India for the first time to a medical device that has been approved by the FDA as a treatment option specifically studied and clinically validated for their particularly complex and potentially life-threatening health conditions. Historically patients with diabetes who undergo PCI have been a difficult-to-treat patient population. They tend to 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.
Medtronic offers a broad range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide.