Medtronic touted the In.Pact Admiral as having demonstrated "the best clinical outcomes ever reported for this disease state."
The FDA approval, which came without a hearing before an agency advisory panel, is for treatment of the superficial femoral and popliteal arteries, using the In.Pact Admiral’s coating of the anti-restenosis drug paclitaxel, according to a press release. The drug-eluting balloon won CE Mark approval back in 2009 in the European Union, where Medtronic said it’s been used to treat nearly 100,000 patients.
Late last month 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, published online Dec. 3 in the American Heart Assn. journal Circulation.
"Having shown success in Europe for several years, we are excited to bring the In.Pact Admiral drug-coated balloon to patients and physicians in the U.S.," aortic & peripheral vascular senior vice president Tony Semedo said in prepared remarks. "In addition to being a key growth driver, the In.Pact Admiral DCB delivers on our commitment to providing innovative technologies that not only provide clinical benefit, but also economic value."
"The introduction of drug-coated balloons represents a significant breakthrough that might establish a new standard of care with its potential to change the way we treat peripheral artery disease in the leg," added investigator Dr. Michael Jaff of the Mass. General Hospital. "Data from clinical trials evaluating this new drug-coated balloon have consistently demonstrated improved patient outcomes."
Last October the FDA approved C.R. Bard‘s (NYSE:BCR) Lutonix DEB, well ahead of the company’s expectation for approval early this year.