FDA Reduces Clinical Trial Endpoint for Angioplasty Device

Intact Vascular announced the FDA approved its request to alter the primary endpoint in a clinical trial for its new device from12 to six months.

The multi-center, single-arm study aims to investigate the safety and efficacy of Intact’s Tack device, an endovascular system designed to repair tears in the artery wall, a frequent balloon angioplasty complication. The company is sponsoring three clinical trials, enrolling the first patient in February.

The FDA decision will help speed the system to market, according to Intact Vascular President and CEO Bruce Shook. The second of the three trials is the first known FDA-approved, industry sponsored clinical trial to investigate permanent vascular implants in below-the-knee arteries.