US-based Intact Vascular has completed the patient enrollment in the Tack Optimized Balloon Angioplasty (TOBA) study, a multi-center study designed to collect confirmatory data on the use of Tack-It Endovascular System in the superficial femoral and popliteal arteries.
A total of 138 subjects have been enrolled with 12-month follow-up planned in the TOBA study being conducted at 12 additional European centers.
The Tack-It Endovascular System includes a multi-loaded catheter containing four self-expanding nitinol tacks.
The system is designed to leave minimal foreign material in the artery; to apply a low outward force on the arterial wall; to allow spot treatment only where needed and optimize angioplasty by creating tissue apposition.
Intact Vascular Clinical Affairs vice president Joseph Giorgianni noted the company is grateful to the investigators and their staffs in working with it to reach this milestone.
"They are a dynamic group who are committed to this study. They too are looking forward to the final clinical results after using this new novel technology," Giorgianni added.
Intact Vascular president and CEO Carol Burns noted the company’s technology is unique in that each Tack size can treat a range of vessel diameters, while maintaining low outward forces.
"These product offerings are designed to enable physicians to treat the leg arteries with only two device sizes," Burns added.
Intact Vascular has also developed a device specifically designed for below the knee treatment in addition to the Tack-It Endovascular System used in this study.