Intact Vascular Completes Enrollment for TOBA II BTK Trial
January 3, 2019—Intact Vascular, Inc. announced that it has completed enrollment ahead of schedule for its TOBA II BTK clinical trial.
TOBA II BTK is a single-arm prospective trial designed to evaluate the safety and efficacy of the company's Tack endovascular system for the repair of postangioplasty dissections in the mid/distal popliteal, tibial, and peroneal arteries. According to Intact Vascular, this is the first pivotal trial investigating a permanent vascular implant in below-the-knee (BTK) arteries.
The study enrolled 233 patients with critical limb ischemia (CLI) who were treated using standard balloon angioplasty and consequently experienced at least one dissection requiring repair. Patients were enrolled at 41 United States and European locations.
“Patients with [CLI] experience painful symptoms and are at increased risk of amputation. Unfortunately, therapeutic options are very limited, and no scaffolding solutions are currently FDA-approved for BTK interventions,” commented George Adams, MD, MHS, Coprincipal Investigator for the TOBA II BTK trial, in the company’s announcement. “The potential to have a treatment option that maintains vessel integrity and improves blood flow will have a significant clinical impact for treating patients with [BTK] disease.” Dr. Adams is also Director of Cardiovascular and Peripheral Vascular Research at UNC Rex Hospital in Raleigh, North Carolina.
Patrick Geraghty, MD, who is also Coprincipal Investigator for the TOBA II BTK trial, commented in the announcement, “Dissections are an expected consequence from balloon angioplasty, yet can have significant implications for patients. Early results with the Tack implant are promising, and I look forward to integrating this technology into my [BTK] treatment algorithm.” Dr. Geraghty is Professor of Surgery and Radiology at the Washington University School of Medicine in St. Louis, Missouri.
Intact Vascular advised that the Tack endovascular system is an investigational device limited by United States law for investigational use only; it is not available for sale or use in the United States. The Tack endovascular system received European CE Mark approval in 2017 for the repair of arterial dissections following BTK percutaneous transluminal angioplasty.