Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that data from its Tack Optimized Balloon Angioplasty (TOBA) II pivotal clinical trial will be presented at the 15th Annual VIVA Conference in Las Vegas, NV on November 5-8.
The TOBA II trial is the first-of-its-kind designed to investigate the safety and efficacy of the Tack Endovascular System® for the repair of post-angioplasty dissections in femoropopliteal arteries. The Tack Endovascular System, a dissection repair device that is pre-loaded with 6 self-expanding nitinol devices for above-the-knee (ATK) interventions, can be deployed to treat multiple dissections using a single catheter and leave behind >70% less metal than stents. Patients with peripheral arterial disease (PAD) who are treated with balloon angioplasty often suffer from dissections or tears in the artery wall. Dissections can result in acute thrombosis and occlusions if left untreated, and can lead to recurrent or worsening symptoms and repeat procedures.
"The TOBA II data being presented at VIVA provide important clinical evidence regarding the therapeutic effectiveness of treating dissections with Tack® implants in a challenging patient population," said Peter Schneider, MD, Vascular Surgeon at Kaiser Permanente in Honolulu, Hawaii, and Co-Founder and Chief Medical Officer of Intact Vascular. "Patients with peripheral arterial disease who are treated with balloon angioplasty and suffer dissections, or tears, in their artery wall are subject to increased risk of occlusions. We look forward to sharing the findings from the TOBA II trial, a first-of-its-kind pivotal trial studying the Tack Endovascular System in patients with 100% dissected vessels."