Plenty of companies make drug-eluting stents now. And with that competitive environment in mind, Medtronic ($MDT) has taken an interesting track for one of its products in the space: Getting it approved for as many indications as possible.
The Minnesota device giant disclosed this week at the EuroPCR conference in Paris that it has gained a CE mark for its Resolute Integrity Coronary Stent System for a number of indications. Surgeons can now use the product to treat acute coronary syndromes, acute myocardial infarction, unstable angina, bifurcations, total occlusions, chronic total occlusions and in-stent restenosis, adding to the diabetes mellitus and multi-vessel disease indications it already has in the EU.
Essentially, the big change here is the Resolute Integrity drug-eluting stent has gone from two approved indications in Europe to 9. The stent already has some novelty. In the U.S., it is the only drug-eluting stent FDA-approved for diabetic patients. Now the product stands out in the European Union as having the "broadest range" of approved indications in the continent, Medtronic claims. The company said its coronary business grew about 3% in its fiscal 2012 third quarter, and more indications will only help it boost those numbers in a sector that continues to struggle over concerns, based on some studies, that drug-eluting stents may increase stroke and heart attack risks in some cases.
Medtronic relied on its Resolute All Comers and Resolute International studies to generate data for its European regulatory submission. And those results have been promising, to say the least. The Resolute All Comers randomized control trial, for example, compared the Resolute drug eluting stent to Abbott's Xience V, and Medtronic generated better safety and efficacy data based on three-year follow-up results. Clinicians enrolled more than 2,300 patients in Europe and Israel. For the EuroPCR conference, Medtronic also expects to present two-year results from the All Comers and International trials on Thursday, looking at patients with bifurcation lesions and in-stent restenosis.
- here's the release