Fridley, Minn.-based Medtronic said the 1st uses after FDA approval took place this week in New York City, Detroit, Yuma, Ariz., and Houma, La.
The FDA on Jan. 5 approved the In.Pact Admiral for treatment of the superficial femoral and popliteal arteries, using a coating of the anti-restenosis drug paclitaxel. Medtronic, which last week closed its $50 billion acquisition of Covidien, said the mega-merger "significantly expands Medtronic’s peripheral vascular sales force."
Medtronic is going head-to-head against C.R. Bard‘s (NYSE:BCR) in the U.S. DEB market. The FDA approved the Lutonix device in October 2014, well ahead of the company’s expectation for approval early this year.
“As an investigator in the clinical trial that contributed to this device’s FDA approval, I have seen firsthand how well the In.Pact Admiral drug-coated balloon works as a treatment for peripheral arterial disease in the upper leg," said Dr. William Gray, of the NewYork-Presbyterian Hospital/Columbia University Medical Center, in prepared remarks. "Based on the trial results, which were recently published in the journal Circulation, I see the In.Pact Admiral DCB fast becoming a first-line therapy option for patients with this condition."
Late last year Medtronic said its In.Pact SFA trial showed that the device performed better than standard angioplasty in treating PAD in the upper leg; today the company said the trial delivered "the lowest clinically-driven target lesion revascularization rate ever reported for an interventional treatment of PAD in the superficial femoral artery."
After 12 months, the target lesion revascularization rate for the In.Pact Admiral group was 2.4%, compared with 20.6% of PTA patients. The drug-eluting balloon group showed a primary patency rate (freedom from restenosis or clinically driven TLR) of 82.2%, compared with 52.4% for the control group, according to the study.