Intact Vascular, a developer of medical devices for minimally invasive peripheral vascular procedures, has 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.
A total of 35 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.
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: 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 4F multi-loaded catheter containing three self-expanding nitinol tacks.
Intact Vascular president and CEO Carol A Burns noted 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," Burns added.