Intact Vascular said today that it won CE Mark approval in the European Union for its Tack endovascular system to repair arterial dissections after percutaneous transluminal angioplasty below the knee. The indication extends the system’s use in the EU to the tibial arteries between the knee and the ankle.
The Tack implant can be used in arteries ranging from 1.5 mm to 4.5 mm in diameter and unlike stents, it adapts to the diameter of the artery, according to Wayne, Penn.-based Intact Vascular.
The CE Mark was supported by data from the company’s TOBA BTK clinical trial, which examined the use of the Tack device to repair dissections in tibial arteries following PTA. The data showed 78.4% patency after 12 months and a 93.5% freedom from re-intervention.
“Critical limb ischemia is a serious disease that all too often leads to amputation. It is vital that we develop new technologies to restore and maintain blood flow to the lower leg and foot,” TOBA II BTK principal investigator Dr. Andrej Schmidt said in prepared remarks. “The Tack Endovascular System represents a major step forward in the endovascular treatment of CLI and offers us a new approach to repairing injured arteries following angioplasty.”
“Our experience in the TOBA BTK clinical study demonstrated that repairing dissections with the Tack implant immediately following angioplasty helps keep treated blood vessels open at 12 months, which is an important step toward limb salvage,” TOBA BTK principal investigator Dr. Marianne Brodmann added. “Attainment of the CE Mark is welcome news for CLI patients and those of us who treat them.”
Intact Vascular also recently won an investigational device exemption for the TOBA II BTK study. The trial is the 1st approved by the FDA for the treatment of critical limb ischemia with a vascular implant below the knee, according to the company.