Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the start of enrollment in the Tack Optimized Balloon Angioplasty Below the Knee (TOBA-BTK) study. This multi-center pilot study will gather data supporting the safety and performance of the Tack-It Endovascular System™ in subjects with Critical Limb Ischemia (CLI) 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.
Professor Marianne Brodmann, M.D. (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.
Critical Limb Ischemia (CLI) is an advanced stage of peripheral artery disease in which patients suffer from inadequate blood flow to the lower leg and foot. If left untreated, this may lead to pain, gangrene and tissue loss (amputation). A balloon angioplasty is the most common procedure performed to attempt to restore blood flow in these blocked arteries. However, intimal dissection often occurs at the angioplasty site producing a nidus for thrombotic occlusion. The Tack-It device is designed to restore tissue apposition at the site of such local 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 reestablish intimal apposition, and 3) to allow “spot” treatment only where needed. The System is composed of a 4F multi-loaded 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 Marianne Brodmann, M.D. 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 POBA.” “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 US,” stated President and CEO Carol A. Burns.