November 5, 2019
Six-Month Data From Intact Vascular TOBA II BTK Trial Presented
November 6, 2019—Intact Vascular, Inc. announced that the 6-month results of its Tack Optimized Balloon Angioplasty (TOBA) II below-the-knee (BTK) clinical trial achieved all primary (P < .0001) and secondary endpoints with very low rates of major amputation and all-cause death. The study focused on patients with critical limb ischemia.
George Adams, MD, Coprincipal Investigator of the TOBA II BTK trial, presented the data during a late-breaking clinical trial session at VIVA 2019, the Vascular InterVentional Advances meeting held November 4–7 in Las Vegas, Nevada.
According to the company, the prospective, single-arm TOBA II BTK study was conducted at multiple sites across Europe, New Zealand, and the United States to investigate the safety and effectiveness of the company’s permanent vascular implant for arteries BTK. All patients were implanted with the Tack endovascular system to treat dissections resulting from percutaneous transluminal angioplasty in the mid/distal popliteal, tibial, and/or peroneal arteries.
The TOBA II BTK clinical trial enrolled 233 patients, which included a particularly challenging population (65.7% with diabetes; 83.7% with baseline Rutherford classification, 4 or 5; 47.6% with chronic total occlusions). A total of 341 dissections were treated with Tack implants and demonstrated 100% acute dissection resolution, with 73.8% of wounds healed or improved at 6 months.
Additionally, patients at 6 months demonstrated 95.7% amputation-free survival, 87.3% target lesion patency with significant improvement in toe-brachial index, and 92% freedom from clinically driven reintervention per Kaplan-Meier estimates.
Dr. Adams commented in the company’s announcement, “This trial is the first study to enroll patients with advanced BTK disease and 100% dissected vessels. 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 BTK arterial disease.” Dr. Adams is Director of Cardiovascular and Peripheral Vascular Research, UNC Rex Hospital, in Raleigh, North Carolina.
Additional coprincipal investigators for the trial include 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, in Germany.
Intact Vascular noted that these results will support the company’s premarketing approval application for a BTK indication. Pending FDA approval, the company anticipates a United States commercial launch in the first half of 2020.