September 19, 2016 — Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT Admiral drug-coated balloon (DCB) as a treatment for in-stent restenosis (ISR) in patients with peripheral artery disease (PAD). This is the first DCB that has gained approval to treat ISR in the United States. FDA approval was based on ISR data from the IN.PACT Global Study compared to a standard percutaneous balloon angioplasty (PTA) control.
"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. "Until now physicians have had limited treatment options to address patients with ISR. The FDA's approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven and safe technology."
ISR occurs when a stent is placed in the artery to restore blood flow but over time plaque can form in and around the stent. This condition is estimated to occur in up to 40 percent of all stents placed in the superficial femoral artery (SFA).
Real-world data from the IN.PACT Global Study demonstrating safe and effective treatment of complex ISR lesions was first presented on the scientific podium at VIVA 2015. 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.
The IN.PACT Admiral drug-coated balloon is a clinically-proven, cost-effective primary endovascular therapy that enables physicians to treat claudication and restenosis for patients with superficial femoral artery (SFA) disease. The DCB's primary mode of action is physical dilatation of the vessel lumen by PTA, and the proven paclitaxel drug is intended to prevent artery narrowing by minimizing scar tissue formation.
IN.PACT Admiral DCB received the CE Mark in 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries.
For more information: www.medtronic.com