Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion.
The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said.
“This expanded indication will allow physicians the option to treat these more complex CTO cases with the Resolute Onyx DES, which has shown strong clinical performance across a variety of vessel sizes and anatomies. Medtronic is committed to helping interventional cardiologists better treat the tough, complex coronary cases that have historically required more invasive treatment options, such coronary artery bypass grafting, or open-heart surgery,” coronary and renal denervation biz GM Dave Moeller said in a press release.
Medtronic said that the clearance came supported by data from the single-center, observational, 183-patient PERSPECTIVE study. Results from the study indicated that patients treated with the Resolute DES had a 1.1% average rate of repeat revascularization, 2.2% rate of cardiac death and a 0.6% rate of stent thrombosis at one year.
“Revascularization of CTO presents physicians with many challenges – both regarding procedural technique and tools – given the patient and disease complexity. In part because of these challenges, CTO remains undertreated in interventional cardiology. The newest-generation, thin-strut Resolute Onyx DES, in particular, is well-suited to address the procedural challenges of deliverability and conformability, with now demonstrated excellent early and late safety and efficacy,” principal study investigator Dr. David Kandzari of Atlanta’s Piedmont Heart Institute said in a prepared statement.
Earlier this month, Medtronic said that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons.