Medical device giant Medtronic (NYSE:MDT) won yet another European regulatory approval for its Resolute Integrity drug-eluting stent, with the new labeling including treatment alongside dual-antiplatelet therapy.
The 1-month DAP therapy labeling on the Resolute Integrity is the shortest such treatment indication for any device of its kind, Medtronic said. DAP therapy recommendations vary by geography, but generally accepted treatment requires daily compliance for 6 to 12 months.
It’s the latest win for the Resolute Integrity line, which late last month won FDA clearance for 2 additional sizes of the stent.*
Dual antiplatelet therapy is intended to reduce the risk of the formation of blood clots inside the stented artery, Medtronic reported. However, long-term use of the treatment can cause bleeding problems.
"One year data from the RESOLUTE Clinical Program indicates low stent thrombosis rates for those who interrupted or discontinued DAPT any time after 1 month," the updated device labeling states. "While physicians should continue to adhere to current ESC or ACC/AHA/SCAI guidelines for PCI, patients who interrupt or discontinue DAPT medication one month or more after stent implantation are considered at low risk and showed no increased risk for stent thrombosis."
Medtronic has been touring the Resolute Integrity stent in recent months, with a commercial launch in India in September 2012 and initial sales in Japan just a month before.
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 coronary artery disease, and they represent a difficult-to-treat population, a Medtronic spokesperson told MassDevice.com at the time.
*Correction: This article mistakenly stated that the Resolute Integrity last month won additional CE Mark approvals for new sizes of the stent. The regulatory wins were from the FDA.