Single-Center TOBA Study’s 24-Month Results Presented for Intact Vascular's Tack Endovascular System
November 16, 2017—Intact Vascular, Inc. announced that positive single-center 24-month results from its Tack Optimized Balloon Angioplasty (TOBA) clinical study were presented by Christian Wissgott, MD, at the 2017 VEITHsymposium held November 14–18 in New York, New York. Dr. Wissgott is Assistant Director, Westküstenklinikum Heide in Heide, Germany.
According to the company, the TOBA study enrolled 138 patients at 13 sites in Europe. All study participants had peripheral artery disease caused by blockages in the superficial femoral or popliteal arteries. All participants underwent percutaneous balloon angioplasty, with repair of any dissections resulting from percutaneous balloon angioplasty using Intact Vascular's Tack endovascular system.
Dr. Wissgott’s Kaplan-Meier patency results at 24 months were unchanged from the favorable 12-month rate of 87.5%.
In the company's press release, Dr. Wissgott commented, “The Tack implant offers a new paradigm for focal dissection repair in the superficial femoral or popliteal arteries. Zero reduction in vessel patency over 12 months appears to be attributable to the Tack design, which leaves 70% to 80% less metal behind when compared to traditional stents. In addition, the Tack’s lower chronic outward force minimizes vessel inflammation and reduces vessel trauma that can contribute to restenosis.”
Intact Vascular stated that the design of the Tack endovascular system, which is used for precise dissection repair after balloon angioplasty, helps maintain vessel integrity and maximize blood flow to promote healing, improve outcomes, and save limbs. The system leaves a minimal amount of metal in the artery, reduces mechanical stress on the arterial wall, and preserves future treatment options. The Tack endovascular system has received European CE Mark approval. In the United States, it is an investigational device and is not available for sale or use, advised the company.