FDA approves Medtronic’s In.Pact Admiral DCB for in-stent restenosis

Medtronic (NYSE:MDT) said today it won FDA premarket approval for its In.Pact Admiral drug-coated balloon with indications for treating in-stent restenosis in peripheral artery disease patients.

The Fridley, Minn.-based medical device giant touted it as the 1st DCB to be cleared to treat ISR in the U.S., saying the approval was based on results from its In.Pact global study comparing the DCB treatment with standard percutaneous balloon angioplasty.

“Prior to the FDA approval of In.Pact Admiral DCB for ISR, physicians were challenged to find a durable treatment for PAD patients, considering the complexity of the disease. Together, in collaboration with physicians in the vascular clinical community, we designed the In.Pact global study to look at challenging lesions in real-world patients. Today, the In.Pact Admiral DCB has demonstrated consistent outcomes across all patient morphologies, and it is the only DCB approved to treat patients with ISR in the U.S,” vice president Mark Pacyna said in prepared remarks.

In-stent restenosis, which occurs when plaque forms around stents originally placed in arteries to restore blood flow, is estimated to occur in up to 40% of all superficial femoral artery stents, Medtronic said.

Data from the study showed an 88.7% rate of primary patency at 1 year in patients treated with the In.Pact Admiral, with a clinically-driven target revascularization rate of 7.3%.

“We are experiencing a paradigm shift in treating patients with complex PAD. 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,” added co-principal investigator Dr. John Laird.

In July, Medtronic said that the FDA approved a longer version of the In.Pact Admiral device, which was originally cleared in January 2015, about 6 years after it won CE Mark approval in the European Union.

Medtronic said the trial showed that the target lesion revascularization for the longer lesions was 5.3%, compared with 32.4% for patients treated with percutaneous transluminal angioplasty, with no device- or procedure-related deaths, no amputations and a 3.9% blood clot rate at 12 months (compared with 5.9% for the PTA cohort).

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