November 6, 2019
Positive six-month data from TOBA II BTK Clinical Trial ( Tack Optimized Balloon Angioplasty, successfully achieved all primary (P < 0.0001) and secondary endpoints with very low rates of major amputation and all-cause death.
George Adams, M.D., M.H.S., Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, Raleigh, North Carolina and Co-Principal Investigator of the TOBA II BTK trial, presented the 6-month data today during the Late-Breaking Clinical Trial session at the 2019 VIVA Conference. The study focused on patients suffering from critical limb ischemia (CLI), a diagnosis associated with high rates of amputation and mortality, that currently effects approximately 3 million patients in the U.S.1,2
“This trial is the first study to enroll patients with advanced below-the-knee disease and 100% dissected vessels,” commented Dr. Adams. “It is very exciting to now have an effective therapeutic option that promotes healing and limb preservation in a complex patient population. With these impressive clinical results, I am confident the Tack implants will significantly improve treatment for below-the-knee arterial disease.”
This prospective, single-arm study was conducted at multiple sites across Europe, New Zealand and the U.S. to investigate the safety and effectiveness of a permanent vascular implant for arteries below the knee. All patients were implanted with the Tack Endovascular System to treat dissections resulting from percutaneous transluminal angioplasty (PTA) in the mid/distal popliteal, tibial and/or peroneal arteries. A total of 341 dissections were treated across the 233 patients enrolled, a particularly 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% 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.
“Currently, patients suffering from the painful and debilitating effects of CLI have limited treatment options and are at an increased risk of amputation,” commented Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular. “The data presented today demonstrates that this purpose-built, below-the-knee implant safely and effectively maintains vessel integrity and improves blood flow to enhance outcomes for patients with advanced disease.”
Additional Co-Principal Investigators for the trial included Patrick Geraghty, M.D., Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri, and Andrej Schmidt, M.D., Division of Interventional Angiology, University Hospital Leipzing, Germany.
“We would like to thank the excellent team of physicians and coordinators who contributed to the success of the TOBA II BTK trial,” stated Bruce Shook, Intact Vascular’s President and CEO. “We are very pleased with the results presented today, which will support our PMA application for a below-the-knee indication. Pending FDA approval, we anticipate U.S. commercial launch in the first half of 2020.”