Intact Vascular has announced the completion of enrolment in the TOBA (Tack optimized balloon angioplasty) study. The purpose of this multicentre study is to gather confirmatory data on the use of the Tack-It Endovascular System in the superficial femoral and popliteal arteries.
This study is co-led by principal investigators Marc Bosiers, St Blasius Hospital (Dendermonde, Belgium) and Dierk Scheinert, Park-Krankenhaus Leipzig (Leipzig, Germany). Twelve additional European centres are also participating in the study, which enrolled 138 subjects with 12-month follow-up planned.
The Tack-It Endovascular System has been designed to leave minimal foreign material in the artery; to apply a low outward force on the arterial wall; and to allow “spot” treatment only where needed. The system is composed of a multiloaded catheter containing four self-expanding nitinol tacks, and is designed to optimise angioplasty by creating tissue apposition.
“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,” commented Marianne Brodmann, a participating physician from the Medical University Hospital Graz in Austria. “I can customise treatment, which allows me to make decisions based on the treatment area, rather than what is on the shelf.”
In addition to the Tack-It Endovascular System used in this study, Intact Vascular has also developed a device specifically designed for below-the-knee treatment. A TOBA BTK trial is planned in the near term.