Following a balloon angioplasty, an artery can sometimes develop a dissection, a potentially serious complication. The Tack endovascular system from Intact Vascular, a Wayne, Pennsylvania firm, received the CE Mark in Europe to be used to repair arterial dissections such as this in tibial arteries below the knee. The Tack consists of tiny stent-like implants and a delivery system that places them at arterial dissection sites. The stents can support arteries from 1.5 mm to 4.5 mm in diameter, so there’s not much need for sizing. Some comments from Intact Vascular regarding what led to the CE Mark clearance:
The CE Mark is supported by a comprehensive review of the data from the TOBA BTK clinical study and extensive in vitro testing. The TOBA BTK study examined use of the Tack device to repair dissections in tibial arteries following PTA. The study demonstrated 78.4% 12-month patency and a 93.5% freedom from re-intervention in arteries treated with PTA and the Tack device. The TOBA BTK results were presented in May 2016 at the Society for Cardiovascular Angiography and Intervention annual meeting and are pending publication.
Here’s an animation explaining the implantation and workings of the Tack endovascular system:
