Medtronic's IN.PACT SFA II Drug-Eluting Balloon Study Completes Enrollment

January 23, 2013–Medtronic, Inc. (Minneapolis, MN) announced completion of enrollment in IN.PACT SFA II, the United States arm of its clinical study for the In.Pact Admiral drug-eluting balloon as a treatment for peripheral artery disease in the superficial femoral (SFA) and proximal popliteal arteries.

According to the company's announcement, IN.PACT SFA II is a prospective, multicenter, randomized controlled trial that enrolled 181 patients at more than 40 sites in the United States and randomized them 2:1 to treatment with either the In.Pact Admiral drug-eluting balloon (study arm) or a traditional, noncoated angioplasty balloon (control arm). The study's primary efficacy endpoint is primary patency at 12 months.

The principal investigators of the IN.PACT SFA II study are interventional cardiologist John Laird, MD, and vascular surgeon Peter Schneider, MD. Dr. Laird is Professor of Medicine at the University of California Davis and Medical Director of the UC Davis Vascular Center. Dr. Schneider is Chief of the Vascular Therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu, Hawaii.

Medtronic advised that 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 US Food and Drug Administration.

“The European experience with In.Pact drug-eluting balloons shows a promising interventional treatment for peripheral artery disease in the lower extremities,” commented Prakash Krishnan, MD, in Medtronic's press release. Dr. Krishnan is Assistant Professor of Medicine and Director of Endovascular Intervention at Mount Sinai Heart in New York, New York, and the highest enroller of patients in IN.PACT SFA II. He added, “We look forward to sharing the United States experience of this innovative medical technology as the results of IN.PACT SFA II become available.”

Medtronic also announced that results of European studies involving In.Pact drug-eluting balloons continue to be reported. Findings from the PACIFIER trial were recently published by Michael Werk, MD, et al in Circulation: Cardiovascular Interventions (2012;5:831-840). The PACIFIER data showed a clinically driven target lesion revascularization rate at 12 months of 7.1% for the In.Pact Pacific drug-eluting balloon versus 27.9% for the noncoated balloon control arm (P = .02).

As summarized in the company's press release, the prospective, multicenter, core-lab-adjudicated, randomized controlled PACIFIER trial enrolled 85 patients with femoropopliteal lesions. The study was conducted in three German institutions and included 91 randomized patients, 44 patients treated with a drug-eluting balloon (study arm) and 47 patients treated with a noncoated balloon (control arm).

The study met its primary endpoint by showing a statistically significant difference in reduction of late lumen loss at 6 months for the cases that used a drug-eluting balloon as compared to those that used a non-coated balloon (−0.01 mm vs 0.65 mm; P = .001). 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% vs 34.9%; P = .003). All three of the major adverse events in the study arm were target lesion revascularizations; the control arm included 15 target lesion revascularizations and three deaths. None of the patients in the study had an amputation.

Medtronic advised that the ongoing global IN.PACT clinical program includes 29 studies involving more than 4,600 patients at approximately 230 sites worldwide to investigate Medtronic's In.Pact drug-eluting balloons for the treatment of arterial disease in a variety of vessel beds. As part of this program, Medtronic is currently enrolling the IN.PACT Global study, a real-world evaluation of the In.Pact drug-eluting balloons involving 1,500 patients with femoropopliteal lesions of any length at up to 80 sites worldwide.

According to Medtronic, the In.Pact drug-eluting balloons feature the company's FreePac formulation of paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall. The devices received CE Mark approval in 2008 and 2009 and are available in many countries around the world. In the United States, the In.Pact Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption granted by the US Food and Drug Administration. Currently, no drug-eluting balloons are commercially available in the United States, noted the company.