The study is being led by principal investigators Marc Bosiers, M.D., St. Blasius Hospital (Dendermonde, Belgium) and Dierk Scheinert, M.D., Park-Krankenhaus Leipzig (Leipzig, Germany). Twelve additional European centers also are participating in the study, which enrolled 138 subjects with a 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 to leave minimal foreign material in the artery; apply a low outward force on the arterial wall; and 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,” said 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 at Intact Vascular, added, “We are grateful to the investigators and their staffs in working with us to reach this milestone. They too are looking forward to the final clinical results after using this new technology.”
In addition to the Tack-It Endovascular System used in this study, Intact Vascular also has developed a device specifically designed for below the knee (BTK) treatment. A TOBA BTK trial is planned in the near term.
“Each Tack size can treat a range of vessel diameters, while maintaining low outward forces,” Intact President/CEO Carol Burns said. “These product offerings are designed to enable physicians to treat the leg arteries with only two device sizes.”
Intact Vascular is a privately held medical device company in Wayne, Pa., 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.