Intact Vascular Begins TOBA-BTK Study of Tack-It Endovascular System

December 17, 2013—Intact Vascular, Inc. (Wayne, PA) announced the start of enrollment in the Tack Optimized Balloon Angioplasty Below-the-Knee (TOBA-BTK) study. This multicenter pilot study will gather data supporting the safety and performance of the company’s Tack-It endovascular system in patients with critical limb ischemia caused by vascular disease below the knee. 

TOBA-BTK Principal Investigator, Professor Marianne Brodmann, MD, from the Medical University Hospital Graz in Graz, Austria, performed the first case in the study, which will enroll 35 patients. The tibial vessels targeted for treatment can range from 1.5 to 4.5 mm in luminal diameter, all of which can be treated using the Tack-It endovascular system, advised the company.

In the company’s press release, Prof. Brodmann commented, “Stents—including balloon-expandable, self-expandable, or even drug-eluting stents—have not been successful in treating the arteries below the knee. Now, we are studying a smaller, less-metal solution, and I believe physicians will like this for their patients. I like that I can treat only the segment in the artery where there is dissection. The device was easy to place with very precise positioning of the tacks. The Tack-It device is a nice complement to the current treatment for below the knee, which is ‘POBA’ (plain old balloon angioplasty).”

According to Intact Vascular, the Tack-It endovascular system is designed to restore tissue apposition at the site of intimal dissection, which often occurs at the angioplasty site and produces a nidus for thrombotic occlusion. The Tack-It device has been designed to leave minimal foreign material in the artery, to apply only the minimum outward force required to reestablish intimal apposition, and to allow spot treatment only where needed. The system is composed of a 4-F multiloaded catheter containing three self-expanding nitinol tacks.

On October 1, the company announced completion of enrollment in the TOBA study, which is being conducted to gather confirmatory data on the use of the Tack-It endovascular system in the above-the-knee superficial femoral and popliteal arteries.