DCB receives FDA approval to treat in-stent restenosis in patients with PAD

Medtronic announced the FDA has approved its drug-coated balloon for treatment of in-stent restenosis in patients who have peripheral artery disease.

Perspective from Curtiss T. Stinis, MD, FACC, FSCAI

The DCB (IN.PACT Admiral) is the first device to be approved in the United States for that indication, the company stated in a press release.

Approval was based on results from the IN.PACT Global study, according to the release.

In results from IN.PACT Global presented at VIVA 15 in November, the DCB was associated with an 88.7% primary patency rate and a 7.3% clinically driven target lesion revascularization rate at 12 months in real-world patients with femoropopliteal lesions, some of whom had de novo in-stent restenosis lesions.

Those findings plus additional results provided to the FDA were compared with historical data on treatment of peripheral in-stent restenosis with percutaneous transluminal angioplasty, according to the release.

John Laird

“We are experiencing a paradigm shift in treating patients with complex PAD,” John Laird, MD, interventional cardiologist at University of California – Davis Medical Center, Sacramento, and co-principal investigator of the IN.PACT SFA trial, said in the release. “Until now, physicians have had limited treatment options to address patients with [in-stent restenosis]. The FDA’s approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven and safe technology.”

Disclosure: Laird reports consulting and serving on advisory boards for Abbott Vascular, Bard, Boston Scientific and Medtronic, and receiving research support from Gore and Medtronic.

Perspective

Curtiss T. Stinis, MD, FACC, FSCAI

p>DCBs are a true game-changing technology for the treatment of PAD. We know that the treatment of arteries using conventional balloon angioplasty leads to an inflammatory response and a cascade of events which includes neointimal hyperplasia and restenosis. DCBs are coated with antiproliferative agents which penetrate into the vessel tissues and disrupt the cell cycle to reduce or eliminate the neointimal hyperplastic response. DCBs have changed current clinical practice and have become the “go to” therapy for de novo lesions in the superficial femoral and popliteal arteries. Many patients, however, still require stenting due to vessel recoil or significant dissection, or already have older-generation stents implanted. These patients are at risk for the development of in-stent restenosis, treatment of which is challenging because use of conventional balloon angioplasty leads to suboptimal results in the short and long term, and the use of atherectomy devices for debulking is minimally effective, potentially risky and not well-studied. The recent results from the IN.PACT Global study are truly exceptional and confirm that DCB technology has become the new standard for the treatment of femoropopliteal disease.

Curtiss T. Stinis, MD, FACC, FSCAI

Director, Peripheral Interventions

Director, Interventional Cardiology Fellowship Program

Scripps Clinic/Scripps Health, La Jolla, California

Disclosures: Stinis reports consulting for Abbott Vascular, Cook Medical and Medtronic.