Intact Vascular said it’s launching a multi-center pilot study for its Tack-It endovascular system for treating peripheral artery disease.
The trial, TOBA-BTK, is designed to gather data supporting the safety and performance of the Tack-It system in subjects with critical limb ischemia due to vascular disease below the knee.
The Tack-It system is designed to leave minimal foreign material in the artery, 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 4F multi-loaded catheter containing 3 self-expanding nitinol tacks, according to a press release.
“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 1 step closer to our goal, which is to offer physicians just 2 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 U.S.,” president & CEO Carol Burns said in prepared remarks.