Intact Vascular Completes TOBA-BTK Trial Enrollment

November 4, 2014—Intact Vascular announced the completion of the TOBA-BTK (Tack Optimized Balloon Angioplasty—Below the Knee) study. This multicenter pilot study focused on gathering data supporting the safety and performance of Intact Vascular’s Tack Endovascular System in patients with critical limb ischemia (CLI) due to vascular disease below the knee. Thirty-five patients were enrolled in this study, which targeted diseased tibial vessels for treatment.

According to Intact Vascular, the Tack Endovascular System device is intended to repair tissue tears at the site of postangioplasty dissection. The device has been designed to leave minimal foreign material in the artery, to apply only the minimum outward force required to repair tissue tears within the lumen, and to allow “spot” treatment only where needed. The system is composed of a delivery catheter containing three self-expanding nitinol Tacks.

In the company’s press release, Assistant Professor Christian Wissgott, MD, commented, “CLI is a devastating and costly disease that demands new, innovative treatments. Completion of the TOBA-BTK trial is an important step toward developing an important new tool that could ultimately save the limbs of patients suffering from CLI.” Prof. Wissgott, who was a leading enroller in the trial, is Deputy Chief, Institute of Diagnostic and Interventional Radiology at Westkuestenklinikum Heide, Germany.

Peter Schneider, MD, added, “Our best method for salvaging threatened limbs is to revascularize them using balloon angioplasty, but the current technique has limitations. The Tack Endovascular System has the potential to substantially improve outcomes for CLI patients by optimizing angioplasty.” Dr. Schneider, who is Chief of Vascular Therapy at Kaiser Foundation Hospital in Honolulu, Hawaii, serves as Intact Vascular’s Chief Medical Officer.