Medical device giant Medtronic (NYSE:MDT) won expanded FDA approval for new sizes of its Resolute Integrity drug-eluting stent, the only devices of its kind with regulatory indication for treatment in patients with diabetes.
The new sizes allow for treatment of long coronary lesions, those which span more than 27mm, according to Medtronic.
"Long coronary lesions and diabetes represent 2 distinct but often interrelated clinical challenges," cardiologist Dr. Ronald Caputo said on behalf of the company. "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 device initially won FDA approval in February 2012, almost exactly 1 year ago to the day. Diabetic patients make up about ⅓ of all those with cornary artery disease, and they represent a difficult-to-treat population, a Medtronic spokesperson told MassDevice.com at the time.
"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," according to the company. "As a result, many of these patients have undergone open heart surgery."
The Resolute Integrity features "continuous sinusoid technology," meaning it’s made with a continuous strand of wire that makes each stent comparable to a flexible spring and aims to provide more deliverability than alternative stents.
"Based on how well the Resolute Integrity has performed outside of the U.S., where it has been available since fall of 2010, we expect it to do quite well in the U.S. where it has had few competitors," Medtronic spokesman Joe McGrath told MassDevice last year.