Medtronic (NYSE:MDT) said a new study found that its drug-eluting balloon performed better than a standard angioplasty balloon in the treatment of symptomatic peripheral artery disease of the upper leg.
The Medtronic-sponsored In.Pact SFA study compared the outcomes of 331 PAD patients in Europe and the U.S. whose narrowed leg arteries were treated either with standard percutaneous transluminal angioplasty or Medtronic’s In.Pact Admiral balloon.
After 12 months, the target lesion revascularization rate for the In.Pact Admiral group was 2.4%, compared with 20.6% of PTA patients. The drug-eluting balloon group showed a primary patency rate (freedom from restenosis or clinically driven TLR) of 82.2%, compared with 52.4% for the control group, according to the study, published online Dec. 3 in the American Heart Assn. journal Circulation.
"In this prospective, multicenter, randomized trial, [drug-eluting balloon] was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal PAD," the authors wrote.
"To put the results in context, patients in the study’s [DEB] group experienced the highest rate of primary patency and the lowest rate of clinically-driven target lesion revascularization at 12 months ever reported from a study of interventional treatments for this common form of peripheral artery disease," Medtronic said.
Medtronic won CE Mark approval in the European Union for the In.Pact Admiral in 2009. In June, Medtronic filed the final module of its pre-market approval application with the FDA.
