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Medtronic initiates U.S. trial to evaluate drug-eluting balloons as treatment for PAD

Friday, April 13 2012 | Comments
Evidence Grade 0 What's This?
Medtronic Inc. initiated the IN.PACT SFA II trial, which is the first U.S. clinical trial of the company's line of IN.PACT drug-eluting balloons as a treatment for peripheral artery disease (PAD).

The Phase II trial is being conducted to evaluate the safety and effectiveness of the IN.PACT Admiral drug-eluting balloon in the treatment of PAD in the superficial femoral artery and/or the proximal popliteal artery. In particular, Medtronic noted, the trial will assess the effect of the device on the treatment of de novo and nonstented restenotic atherosclerotic lesions in these vessel beds.

The trial participants will be randomized to receive Medtronic's drug-eluting balloon or a traditional noncoated angioplasty balloon.

The primary efficacy measure is defined as freedom from clinically driven target lesion revascularization and freedom from restenosis as determined by duplex ultrasound. The primary measure of safety is a composite of freedom from device and procedure-related death through 30 days postprocedure and freedom from both target limb major amputation and clinically driven target vessel revascularization. Both of these primary outcome measures will be evaluated during a 12-month period.

Medtronic's drug-eluting balloons are coated with FreePac, a proprietary formulation consisting of paclitaxel and urea. Urea is an excipient that facilitates absorption of paclitaxel into the vessel wall. The balloons are designed to deliver an antirestenotic agent to the vessel and leave nothing behind.

Data from this trial will be combined with data from the IN.PACT SFA I study, which is under way in Europe. Results from the two trials will form the basis of an application for Food and Drug Administration approval of the balloons. Anticipated enrollment in the trials is approximately 450 patients.

Worldwide, the IN.PACT program will include 24 studies and approximately 4,000 patients in more than 80 countries. The drug-eluting balloons will be assessed in the treatment of arterial disease in coronary and peripheral vessel beds, according to Medtronic.

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