Medtronic has received FDA approval for the first drug-coated balloon to treat in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). ISR occurs when plaque forms in and around a stent that is placed in an artery to restore blood flow. According to Medtronic, ISR occurs in nearly 40% of stents placed in the superficial femoral artery (SFA).

The device, the IN.PACT Admiral drug-coated balloon, will provide a new treatment option for PAD patients. The device received the CE Mark in 2009.

“We are experiencing a paradigm shift in treating patients with complex PAD,” said John Laird, M.D., interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA Trial, in a Medtronic press release. “Until now physicians have had limited treatment options to address patients with ISR.”

Medtronic released the following data about the IN.PACT Global Study:

“The one-year primary patency rate for this difficult to treat patient subgroup in the IN.PACT Global ISR Imaging Cohort was 88.7 percent, and the clinically-driven target revascularization (CD-TLR) rate was 7.3 percent. The mean length of lesions was 17.2 ± 10.5 cm, with 34.0 percent occluded ISR lesions. Additional ISR data from the IN.PACT Global Study and a PTA control were used to gain FDA approval of the ISR indication.”