Hollywood, FL (January 24, 2020) – Critical limb ischemia (CLI) currently affects up to 3.4 million people in the United States and is forecast to exceed 4 million in the next ten years. Plain old balloon angioplasty has historically been the standard therapy, but “has had suboptimal results with about a 31% dissection rate. We typically underestimate these dissections,” noted George Adams, MD, MHS, MBA, North Carolina Heart and Vascular, Rex Hospital, in Raleigh, North Carolina. Dr. Adams, a co-principal investigator, presented six-month data from the Tack Optimized Balloon Angioplasty II (TOBA II) Below the Knee (BTK) trial Friday morning at the International Symposium on Endovascular Therapy (ISET).
TOBA II BTK is a prospective, single-arm, pivotal IDE study looking at the Tack Endovascular System (Intact Vascular) in 233 patients at 41 U.S. and international sites. The trial looked at patients with CLI and angiographic evidence of a dissection post-percutaneous transluminal angioplasty (PTA) requiring repair in the mid/distal popliteal, tibial and/or peroneal arteries ranging in diameter from 1.5 mm to 4.5 mm. TOBA II BTK is the first trial to enroll 100% dissected vessels.
A total of 341 dissections were treated across the 233 patients enrolled, a challenging population with 65.7% suffering from diabetes, 83.7% baseline Rutherford classification of 4 or 5, and 47.6% with chronic total occlusions (CTO).
The Tack implants demonstrated 100% acute dissection resolution, with 73.8% of wounds healed or improved at six months. Results at six months demonstrated 95.7% Kaplan-Meier (K-M) amputation-free survival, 87.3% K-M target lesion patency with significant improvement in toe-brachial index (TBI), and 92.0% K-M freedom from clinically driven reintervention.
Pre-loaded with six self-expanding nitinol devices for above-the-knee (ATK) interventions, or four for BTK interventions, the Tack Endovascular System can be deployed to treat multiple dissections using a single catheter and leaving behind >70% less metal than stents, helping to preserve future treatment options.
Additional co-principal investigators for the trial included Patrick Geraghty, MD, Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri, and Andrej Schmidt, MD, Division of Interventional Angiology, University Hospital Leipzig, Germany.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Tack Endovascular System (6F) is FDA approved for use in the superficial femoral and proximal popliteal arteries, ranging from 3.5mm to 6.0mm reference vessel diameter, for treatment of post-PTA dissections.
Tack Endovascular System (4F) CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.