December 23, 2013 — Intact Vascular Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, 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 Tack-It Endovascular System in 35 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.
Marianne Brodmann, M.D., Medical University Hospital of Graz, Austria, and principal investigator, performed the first case. In the study, the tibial vessels targeted for treatment can range from 1.5 mm to 4.5 mm in luminal diameter using the Tack-It Endovascular System device.
CLI is an advanced stage of peripheral artery disease (PAD) 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. It is also designed to leave minimal foreign material in the artery, apply only the minimum outward force required to reestablish intimal apposition and allow spot treatment only where needed. The system is composed of a 4 French 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,” said Brodmann. “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.”
For more information: www.intactvascular.com