Intact Vascular announced on 17 December 2013 the start of enrolment in the TOBA-BTK (Tack optimized balloon angioplasty below the knee) study. This multicentre pilot study will gather data supporting the safety and performance of the Tack-It Endovascular System in patients with critical limb ischaemia due to vascular disease below the knee. A previously enrolled and ongoing clinical trial recruited patients with claudication due to vascular disease for the above-the-knee indication.
Marianne Brodmann, Graz, Austria, performed the first case and is the principal investigator of the study. Thirty five subjects will be enrolled in this trial. The tibial vessels targeted for treatment can range from 1.5mm to 4.5mm in luminal diameter, all of which can be treated using the Tack-It Endovascular System device.
The Tack-It device is designed to restore tissue apposition at the site of intimal dissection. The Tack-It Endovascular System has been designed: 1) to leave minimal foreign material in the artery, 2) to apply only the minimum outward force required to re-establish intimal apposition, and 3) to allow “spot” treatment only where needed. The system is composed of a 4F multiloaded catheter containing three self-expanding nitinol tacks.
“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,” commented Brodmann, from the Medical University Hospital Graz in Austria. “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 compliment to the current treatment for below the knee which is plain old balloon angioplasty.”
“The development of the smaller, below-the-knee device and the initiation of the TOBA-BTK trial is a significant milestone for the company. This brings us one step closer to our goal which is to offer physicians just two devices to treat the entire leg. This presents a simple, versatile approach which could also reduce inventory costs. We are also pleased to announce that we have closed on additional financing which will be used to fund this trial in Europe and to prepare for our upcoming study in the USA,” stated president and CEO Carol A Burns.