Intact Vascular said today that the FDA approved an investigational device exemption supplemental application to modify the primary endpoint in a below-the-knee clinical trial of its Tack optimized balloon angioplasty from 12 months to 6 months.
The Tack endovascular system is designed to repair dissections that occur as a complication of balloon angioplasty. The system allows operating physicians to repair dissections with only a small amount of foreign material in the artery, the Wayne, Penn.-based company said.
The Toba II BTK study is a prospective, multi-center, single-arm study which looks to investigate the safety and efficacy of the Tack system in combination with standard balloon angioplasty in the popliteal and tibial arteries for treating critical limb ischemia, Intact Vascular said.
“We are very pleased with FDA’s decision to approve our supplemental application to modify the primary endpoint to 6 months. We believe that this will help accelerate the availability of the Tack Endovascular System in the U.S. as an important new endovascular treatment for patients suffering from below the knee arterial disease,” prez & CEO Bruce Shook said in a press release.
Intact Vascular touted the trial as the 1st known industry sponsored pivotal clinical trial of its kind to investigate a permanent vascular implant in arteries below the knee. The company enrolled the 1st patient in the trial in February.