|The Resolute Integrity stent--Courtesy of Medtronic|
Medtronic ($MDT) is working to expand the market share of its Resolute Integrity drug-eluting stent, scoring regulatory approval for an update to the device's CE mark label that bills it as safe for patients who cut thrombosis treatment short.
Patients normally undergo dual antiplatelet therapy, a treatment designed to minimize the risk of clotting inside the artery, for 6 to 12 months after stenting. However, the therapy can lead to bleeding complications all its own, forcing physicians to find a balance.
That's where Resolute Integrity's new European label comes in: According to Medtronic's data, patients who end dual antiplatelet therapy after one month face no increased risk of stent thrombosis, giving Resolute Integrity the shortest minimum duration of treatment of any device on the market, Medtronic says.
The new label, based on data from 5,000 patients around the world, could bolster Resolute Integrity's share of the European drug-eluting stent market, and Medtronic is chasing the same end stateside. Last week, the devicemaker won FDA approval for new sizes of the stent, allowing it to target long coronary lesions.
- read Medtronic's announcement
Correction: An earlier version of this story misidentified the device. We regret the error.