Medtronic, a global healthcare products company based in Minneapolis, Minnesota, announced that it received expanded approval from the United States Food and Drug Administration for its Resolute Integrity stent. The Resolute drug-eluting stent has a specialized design for the treatment of extended-length coronary lesions.
The expanded approval allows the company to market longer versions of the drug-eluting stent for patients with coronary lesions that span more than 27 millimeters.
Dr. Ronald Caputo is a cardiologist who worked on the company’s drug-eluting stents. In prepared remarks, he said, "Long coronary lesions and diabetes represent 2 distinct but often interrelated clinical challenges." He continued, "The new sizes of the Resolute Integrity drug-eluting stent address both challenges in a single device. They have the potential to reduce procedure time and cost for clinicians and hospitals, as well as vessel trauma and contrast exposure for patients."
The company’s Resolute Integrity stent has experienced a variety of regulatory wins around the world over the past year. In February of 2012, the FDA granted initial approval for the drug-eluting stent. At the time, a spokesperson at Medtronic stated that approximately 30 percent of coronary artery disease patients have diabetes. By improving medtech for the diabetic community, the company hopes to improve quality of life and longevity in vulnerable populations.
In September of last year, the device was launched in India. One month before that, the device was introduced in Japan.