Intact Vascular has attained the CE mark for the Tack endovascular system for the repair of arterial dissections following percutaneous transluminal angioplasty (PTA) below the knee. This extended indication in the European Union enables the use of the Tack system in the tibial arteries between the knee and ankle.
The unique mechanical design of the Tack implant allows it to be used in arteries ranging from 1.5mm to 4.5mm in diameter. Unlike stents, which have to be precisely sized to the artery where they will be placed, the Tack implant adapts to the diameter of the artery.
“Critical limb ischaemia (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,” said Andrej Schmidt, Division of Interventional Angiology, University Hospital Leipzig, Germany, and European principal investigator for the TOBA II BTK clinical trial. “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.”
The CE mark is supported by a “comprehensive review” of the data from the TOBA BTK clinical study and “extensive in vitro testing,” says an Intact Vascular press release. 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 reintervention 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.
“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,” said Marianne Brodmann, Head of the Clinical Division of Angiology, Medical University Graz, Austria, and principal investigator for the TOBA BTK trial. “Attainment of the CE mark is welcome news for CLI patients and those of us who treat them.”
Intact Vascular also recently announced Food and Drug Administration (FDA) approval of 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 CLI with a vascular implant below the knee.