Medtronic Completes US Enrollment in Drug-Eluting Balloon Trial

Medical device company Medtronic Inc. has completed enrollment in IN.PACT SFA II, the U.S. arm of its clinical study for the IN.PACT Admiral drug-eluting balloon. The balloons are intended as a treatment for peripheral artery disease in the superficial femoral and proximal popliteal arteries (SFA, the branch of the femoral artery closer to the skin and PPA, the extension of the SFA after passing through lower third of the thigh and past the knee).

IN.PACT SFA II is a prospective, multicenter, randomized controlled trial that enrolled 181 patients at more than 40 sites in the United States, randomizing them 2:1 to treatment with either the IN.PACT Admiral drug-eluting balloon (study arm) or a traditional, non-coated angioplasty balloon (control arm). Its primary efficacy endpoint is primary patency, a measure of blood flow through the treated arterial segment, at 12 months.

The principal investigators of the trial are interventional cardiologist John Laird, M.D., professor of medicine at the University of California Davis and medical director of the UC Davis Vascular Center, and vascular surgeon Peter Schneider, M.D., chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu, Hawaii.

Results of IN.PACT SFA II will be combined with those from IN.PACT SFA I—which previously completed enrollment of 150 patients in Europe—to support a premarket approval application to the U.S. Food and Drug Administration (FDA).

“The European experience with IN.PACT drug-eluting balloons shows a promising interventional treatment for peripheral artery disease in the lower extremities,” said Prakash Krishnan, M.D., assistant professor of medicine and director of endovascular intervention at Mount Sinai Heart in New York, N.Y., and reportedly the highest enroller of patients in IN.PACT SFA II.

Results of European IN.PACT trials continue to be reported: For instance, the December 2012 issue of Circulation: Cardiovascular Interventions featured findings from the IN.PACT PACIFER (paclitaxel-coated balloons in femoral indication to defeat restenosis) trial.

According to published findings, the study met its primary endpoint by showing a statistically significant difference in reduction of late lumen loss (reduction in size of a blood vessel’s interior canal) at six months for the cases that used a drug-eluting balloon as compared to those that used a non-coated balloon. The PACIFIER trial defined major adverse events as death, amputation or target lesion revascularization. At 12 months, there were significantly fewer major adverse events in the study arm as compared to the control arm (7.1 percent versus 34.9 percent). All three of the major adverse events in the study arm were target lesion revascularizations (further percutaneous intervention at the lesion site); the control arm included 15 target lesion revascularizations and three deaths. None of the patients in the study had an amputation.

“With seven femoropopliteal trials featuring IN.PACT drug-eluting balloons presented at medical meetings and five of them already published in peer-reviewed journals, Medtronic is on track to deliver this technology to U.S. physicians in a timely manner with an unprecedented volume of high-quality clinical data to support its adoption,” said Tony Semedo, senior vice president of Medtronic and president of the company’s endovascular therapies business.

The ongoing global IN.PACT clinical program includes 29 studies involving more than 4,600 patients at approximately 230 sites worldwide. Through these company-sponsored and physician-initiated studies, Medtronic’s portfolio of IN.PACT drug-eluting balloons will be investigated thoroughly for the treatment of arterial disease in a variety of vessel beds. As part of this program, Medtronic is currently enrolling patients in the IN.PACT Global study, a “real-world” evaluation of the company’s IN.PACT drug-eluting balloons involving 1,500 patients with femoropopliteal lesions of any length at up to 80 sites worldwide.

IN.PACT drug-eluting balloons feature a proprietary coating called FreePac that is a formulation of paclitaxel and urea, an inactive vehicle that facilitates absorption of the drug into the vessel wall. These received the CE mark in 2008 and 2009 and are available in many countries around the world, but not yet in the United States.

In the United States, the IN.PACT Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption granted by the FDA and is not yet commercially available.

Medtronic is headquartered in Minneapolis, Minn., and provides medical devices in a wide range of market segments.