Medtronic’s Drug-Eluting Balloon Trial is Underway

Minneapolis, Minn.-based Medtronic has commenced the IN.PACT SFA II study, the company’s first U.S. clinical trial for its line of IN.PACT drug-eluting balloons. The SFA I study has been ongoing in Europe led by principal investigator Gunnar Tepe, M.D., chief of radiology at Klinikum Rosenheim in Germany.

Once complete, the data from both trials will be used in a premarket approval application to the U.S. Food and Drug Administration (FDA). The combined enrollment in the two Medtronic studies is expected to total approximately 450 patients. Ultimately, Medtronic’s global IN.PACT clinical program will include 24 studies involving roughly 4,000 patients and 200 sites across more than 80 countries worldwide.

The IN.PACT drug-eluting balloon works by being inserted into the artery affected by atherosclerosis (an artery with thickened walls due to fatty material such as cholesterol) and expanded, while slowly administering a drug over time. The balloons are resorbable so they leave nothing behind when the drug administration process is over.

“Drug-eluting balloons represent an exciting and innovative therapy in the advancement of peripheral artery disease treatment,” said John Laird, M.D., principal investigator in the study. “The concept of delivering an anti-restenotic agent to the vessel while leaving nothing behind is very attractive.”

The enthusiasm surrounding this study is understandable—peripheral artery disease affects an estimated 8 – 12 million people in the United States alone. Lower-extremity peripheral artery disease (PAD) is a prime cause of claudication (ischemic leg pain) and immobility, critical limb ischemia and amputations, and is a common manifestation of cardiovascular disease.
The IN.PACT study will evaluate the safety and effectiveness of the balloon in the treatment of PAD in the superficial femoral artery and/or proximal popliteal artery. The trial will specifically examine the effect of this novel device for treating de novo and non-stented restenotic atherosclerotic lesions in these vessel beds. It will be a randomized study with patients from up to 55 U.S. cities, and patients will be randomized 2:1 to treatment with either Medtronic’s IN.PACT Admiral drug-eluting balloon (study arm) or a traditional non-coated angioplasty balloon (control arm). The principal investigators 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. The first few patients have already been treated in Fremont, Calif., and Indianapolis, Ind.