Minnesota medtech giant Medtronic (NYSE:MDT) released a rave review of its Admiral drug-coated balloon, saying results from its IN.PACT SFA clinical trial demonstrate that Admiral produced "the lowest 12-month clinically-driven target lesion revascularization rate for any peripheral intervention ever studied."
Patients treated with the Admiral device had a 2.4% rate of clinically-driven target lesion revascularization (CD-TLR) at 12 months, compared with a 20.6% rate for patients treated with standard percutaneous transluminal angioplasty (PTA), according to the study.
"Based on the exceptionally high quality of this real-world, registry-based evidence, the IN.PACT Admiral drug-coated balloon is demonstrating unparalleled outcomes for atherosclerotic lesions in the femoro-popliteal vessel bed," OhioHealth/Riverside Methodist Hospital vascular services system medical director Dr. Gary Ansel said on behalf of the company. "The clinical community of cardiovascular specialists is increasingly excited about the prospects for this interventional technology for the non-prosthetic treatment of peripheral artery disease."
The Admiral device is not yet approved through the FDA, but could become the 1st DCB on the U.S. market if all continues to go well with the PMA module Medtronic completed in June. CFO Gary Ellis told investors during a conference call in August that the company hopes to have FDA approval in hand before then of this fiscal year.
Newly unveiled outcomes from the IN.PACT Global study further found that the device helped lower the cost of care while delivering superior patient outcomes, researchers reported. Initial costs were higher with Admiral treatment but follow-up costs including time of discharge to 1 year after surgery were $750 lower in Admiral patients than PTA patients.
That translates to "an incremental cost-effectiveness ratio (ICER) of about $2,900 per repeat revascularization avoided, which compares favorably to other cardiovascular therapies, including coronary drug-eluting stents," Medtronic reported.
MDT shares jumped a couple of points today, trading 1.5% higher to $65.95 as of about 1:50 p.m. EST. The stock has gained 15% since the start of this year.