Intact Vascular has secured CE mark for its Tack Endovascular System for repair of dissections following angioplasty below the knee.
With this marking, the system will now be used in the tibial arteries between the knee and ankle. Intact Vascular claims that its mechanical design lets the system to be used in arteries with thickness ranging between 1.5mm to 4.5mm.
The system has a design which is different from stents which have to be precisely sized to the artery, where they will be placed. It can adapt to the diameter of the artery.
The Tack Endovascular System has received the CE marking after a review of data from TOBA BTK clinical study and in vitro testing. The TOBA BTK study examined the use of the Tack device to repair dissections in tibial arteries after PTA.
The study showed a 78.4% 12 month patency and a 93.5% freedom from re-intervention in arteries with PTA and the Tack device.
Results from the TOBA BTK study were presented in May 2016 at the annual meeting of Society for Cardiovascular Angiography and Intervention and are pending publication.
The USFDA has also given its approval to Intact Vascular for an investigational Device Exemption (IDE) for the TOBA II BTK study.
The TOBA II BTK trial is the first pivotal trial approved by the FDA for the treatment of critical limb ischemia (CLI) with a vascular implant below the knee.
University Hospital Leipzig, Germany Division of Interventional Angiology and TOBA II BTK clinical trial European Principle Investigator Andrej Schmidt said: "Critical limb ischemia (CLI) 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.
“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.”