
Medical device titan Medtronic (NYSE:MDT) touted a string of new indications for its Resolute Integrity drug-eluting stents at this year’s EuroPCR meeting in Paris.
With new clearances in hand, the Resolute Integrity stent is now the DES with the broadest range of indications in Europe and the only DES on the market with indication for treating bifurcated lesions, according to a press release.
Added indications included for patients with acute coronary syndrome, unstable angina, bifurcations and total occlusions, among others. The stent was previously indicated for patients with diabetes mellitus and multi-vessel disease.
Medtronic also unveiled the results from a pair of studies used to support the expanded CE Mark, with 3-year results from the Resolute All Comers study and 2-year results from the Resolute International trial and a pair of pooled analyses from the All Comers trial.
The All Comers study compared the Resolute DES to Abbott’s (NYSE:ABT) Xience V DES, concluding that "the Medtronic device continues to match its chief competitor on important measures of safety and efficacy in long-term follow-up."
The pooled analyses considered patients with bifurcation lesions and in-stent restenosis, and the Resolute DES "performed extremely well in this patient subset," according to a press release.
Medtronic plans to reveal the details of the trials during the conference later this week.
The company also unveiled a pair of trials of its In.Pact drug-eluting balloons, which received CE Mark in 2008 and 2009 but are not on the market in the U.S.
The Bello study compared Medtronic’s In.Pact Falcon to Boston Scientific’s (NYSE:BSX) Taxus DES, finding that the Falcon balloon "may be a viable alternative to drug-eluting stents in treating small coronary vessels that have narrowed due to atherosclerosis, in addition to vessels with in-stent restenosis," co-principal investigator Dr. Antonio Colombo said in prepared remarks.
The Falcon boasted lower rates of major adverse cardiac events, myocardial infarction, target lesion revascularization and target vessel revascularization after 6 months when compared to Taxus in the Bello trial.
Medtronic’s Pacifier study found after 1 year "a statistically significant advantage in preventing the leg’s superficial femoral artery from re-narrowing when using the Medtronic In.Pact Pacific drug-eluting balloon versus conventional, uncoated balloons."
"While preliminary drug-eluting balloon data from uncontrolled trials have been promising, the interventional community has eagerly awaited the results from a randomized trial to validate the clinical benefit of Medtronic’s In.Pact drug-eluting balloons," Dr. Michael Werk, who presented the findings, said in prepared remarks. "Earlier research has hypothesized that drug-eluting balloons can reduce late lumen loss, restenosis rates and the need for repeat target lesion revascularization, and now the one-year results of Pacifier show, in a randomized forum, to what extent these results are possible."
Medtronic plans to conduct a total of 24 In.Pact studies involving about 4,000 patients in more than 80 countries, according to a press release.