Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the completion of enrollment of the Tack Optimized Balloon Angioplasty (TOBA) study. The purpose of this multi-center 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 Drs. Marc Bosiers, St. Blasius Hospital (Dendermonde, Belgium) and Dierk Scheinert, Park-Krankenhaus Leipzig (Leipzig, Germany). Twelve additional European centers are also participating in the study, which enrolled 138 subjects with 12-month follow-up planned.
Balloon angioplasty is the most commonly performed peripheral intervention used to improve blood flow in leg arteries. However, suboptimal results frequently occur due to tissue dissection from the angioplasty intervention itself. If left untreated, acute or late complications can occur, resulting in a re-intervention, tissue loss, or amputation. The Tack-It Endovascular System ™ has been designed: 1) to leave minimal foreign material in the artery; 2) to apply a low outward force on the arterial wall; and 3) to allow “spot” treatment only where needed. The system is composed of a multi-loaded catheter containing four self-expanding nitinol tacks, and is designed to optimize 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, M.D., a participating physician from the Medical University Hospital Graz in Austria. “I can customize treatment, which allows me to make decisions based on the treatment area, rather than what is on the shelf.” Joseph Giorgianni, VP of Clinical Affairs added, “We are grateful to the investigators and their staffs in working with us 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.” 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 (BTK) treatment. A TOBA BTK trial is planned in the near term.
“Our technology is unique in that each Tack size can treat a range of vessel diameters, while maintaining low outward forces,” said Carol Burns, President and CEO. “These product offerings are designed to enable physicians to treat the leg arteries with only two device sizes.” About Intact Vascular Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack-It Endovascular System ™ is designed to optimize peripheral balloon angioplasty results in the treatment of peripheral artery disease. This technology is designed to offer physicians a new treatment paradigm for treating peripheral artery disease. Visit www.intactvascular.com for more information.