Twelve-Month Results Published From TOBA BTK Trial of Intact Vascular's Tack System

March 27, 2018—Intact Vascular, Inc. announced that 12-month results from the Tack Optimized Balloon Angioplasty Below the Knee (TOBA BTK) clinical trial were published online by Prof. Marianne Brodmann, MD, et al in Catheterization and Cardiovascular Interventions.

According to Intact Vascular, this multicenter pilot study focused on collecting data supporting the safety and performance of the company's Intact Tack endovascular system in patients with critical limb ischemia (CLI) caused by vascular disease BTK. The TOBA BTK study targeted diseased tibial arteries for dissection repair after plain balloon angioplasty. Investigators enrolled 35 patients at six sites in Europe and New Zealand.

The company reported that the analysis of the TOBA BTK data demonstrated 1-year primary patency via Kaplan-Meier estimate of 77.4%. Additionally, freedom from clinically driven target lesion revascularization was 93.5%, freedom from clinically driven target vessel revascularization was 93.5%, and amputation-free survival was 84.5%.

In the company's press release, Prof. Brodmann commented, “The number of patients being treated for CLI is rapidly growing, making it vitally important to optimize postangioplasty results and minimize metal burden to improve blood flow and allow wound healing. I believe that the Tack endovascular system provides a promising option to treat postangioplasty dissection in this very challenging patient population.” Prof. Brodmann is Head of the Clinical Division of Angiology, Medical University Graz in Graz, Austria.