Case Study | November 07, 2014

Completion of TOBA-BTK Trial Enrollment to Treat CLI

The Tack Optimized Balloon Angioplasty - Below the Knee Study is completed

balloon angioplasty, clinical trial, clinical study, Intact Vascular, PAD

Nov. 7, 2014 — Intact Vascular, a medical device company and developer of products for minimally invasive peripheral vascular procedures, completed the Tack Optimized Balloon Angioplasty - Below the Knee (TOBA-BTK) Study. 

This multi-center pilot study focused on gathering data supporting the safety and performance of the Tack Endovascular System in subjects with critical limb ischemia (CLI) due to vascular disease below the knee. Thirty-five subjects were enrolled in this study, which targeted diseased tibial vessels for treatment.

Balloon angioplasty is the most common procedure performed to restore blood flow in these blocked arteries. However, post-angioplasty dissection often occurs at the treatment site, which increases the risk of thrombotic occlusion. The Tack device is designed to repair tissue tears at the site of post-angioplasty dissection.

The Tack Endovascular System has been designed:

1) to leave minimal foreign material in the artery

2) to apply only the minimum outward force required to repair tissue tears within the lumen

3) to allow “spot” treatment only where needed. The system is composed of a delivery catheter containing three self-expanding nitinol Tacks.

Assistant Professor Christian Wissgott, M.D., deputy chief, Institute of Diagnostic and Interventional Radiology, Westkuestenklinikum Heide, Germany, who was a leading enroller in the trial.

Peter Schneider, M.D., Intact Vascular chief medical officer and chief, vascular therapy at Kaiser Foundation Hospital in Honolulu, said, “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.”

For more information: www.intactvascular.com 

 

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