January 16, 2017
BTK Indication Approved for Intact Vascular's Tack Endovascular System in Europe
January 17, 2017—Intact Vascular, Inc. announced European CE Mark approval 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 Tack system, which is designed to be used in arteries ranging from 1.5 to 4.5 mm in diameter, adapts to the diameter of the artery.
According to Intact Vascular, the CE Mark is supported by a comprehensive review of the data from the Tack Optimized Balloon Angioplasty—Below-the-Knee (TOBA BTK) clinical study and extensive in vitro testing. The TOBA BTK study examined the use of the Tack device to repair dissections in tibial arteries after PTA and demonstrated 78.4% patency and 93.5% freedom from reintervention in arteries treated with PTA and the Tack device at 12 months. The TOBA BTK results were presented in May 2016 at the Society for Cardiovascular Angiography and Intervention annual meeting and are pending publication.
In the company’s announcement, Prof. Marianne Brodmann, MD, commented, “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. Attainment of the CE Mark is welcome news for critical limb ischemia (CLI) patients and those of us who treat them.” Prof. Brodmann, who is Head of the Clinical Division of Angiology, Medical University Graz, Austria, serves as Principal Investigator for the TOBA BTK trial.
Andrej Schmidt, MD, the European Principal Investigator for the TOBA II BTK clinical trial, added, "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.” Dr. Schmidt is from the Division of Interventional Angiology, University Hospital Leipzig, Germany.
Intact Vascular recently announced US Food and Drug Administration approval of an investigational device exemption for the TOBA II BTK study. The Tack endovascular system is not available for sale or use in the United States, advised Intact Vascular.