Medtronic initiates US drug-eluting Balloon study for peripheral artery disease

Medtronic, Inc. announced today the start of the IN.PACT SFA II study, the company’s first US clinical trial for its IN.PACT drug-eluting balloons. The first patients in this landmark study were treated this week. The study will evaluate the safety and effectiveness of the IN.PACT Admiral drug-eluting balloon in the treatment of peripheral artery disease in the superficial femoral artery and/or proximal popliteal artery. The study will involve several hundred patients at up to 55 US sites. Patients will be randomized to treatment with either the IN.PACT Admiral drug-eluting balloon or a traditional non-coated angioplasty balloon. “Drug-eluting balloons represent an exciting and innovative therapy in the advancement of peripheral artery disease treatment,” said  Dr. John Laird, a principal investigator of the study. “The concept of delivering an anti-restenotic agent to the vessel while leaving nothing behind is very attractive.”