Enrollment Completed in TOBA Study of Intact Vascular's Tack-It System

October 1, 2013—Intact Vascular, Inc. (Wayne, PA) announced the completion of enrollment in the multicenter TOBA (Tack Optimized Balloon Angioplasty) study, which is being conducted to gather confirmatory data on the use of the company's Tack-It endovascular system in the superficial femoral and popliteal arteries.

Coprincipal Investigators Marc Bosiers, MD, and Dierk Scheinert, MD, are leading the study. Dr. Bosiers is affiliated with St. Blasius Hospital in Dendermonde, Belgium, and Dr. Scheinert is affiliated with Park Hospital in Leipzig, Germany. Twelve additional European centers are participating in the study, which enrolled 138 patients. A 12-month follow-up time period is planned.

According to Intact Vascular, the Tack-It endovascular system has been designed to: (1) leave minimal foreign material in the artery, (2) apply a low outward force on the arterial wall, and (3) allow “spot” treatment only where needed. The system is composed of a multiloaded catheter containing four self-expanding nitinol tacks and is designed to optimize angioplasty by creating tissue apposition.

Marianne Brodmann, MD, a TOBA study investigator from the Medical University Hospital Graz in Austria, commented in the company's press release, “I like that I can treat my patients on an individual basis by placing as many tacks as are needed and where I want them. I can customize treatment, which allows me to make decisions based on the treatment area, rather than what is on the shelf.”

Intact Vascular noted that the company has also developed a device specifically designed for below-the-knee treatment, and a TOBA BTK trial is planned in the near future.