WAYNE, Pa.--(BUSINESS WIRE)--Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that it has attained the CE (Conformité Européenne) Mark for the Tack Endovascular System to repair 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 1.5 mm to 4.5 mm 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 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,” said Dr. Andrej Schmidt, Division of Interventional Angiology, University Hospital Leipzig, Germany and European Principle 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. 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.
“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 Professor Dr. 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. See http://www.intactvascular.com/actively-enrolling for more information on Intact Vascular’s clinical development program.
About Intact Vascular
Intact Vascular is a privately held medical device company that develops minimally invasive peripheral vascular products. The Tack Endovascular System is designed to optimize percutaneous balloon angioplasty results in the treatment of peripheral arterial disease. Visit www.intactvascular.com for more information.
This press release contains “forward-looking statements” concerning the development of Intact Vascular's products, the potential benefits and attributes of such products, and the company’s expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. These statements are made as of the date of this press release. Actual results may vary. Intact Vascular undertakes no obligation to update any forward-looking statements for any reason.
Under U.S. Federal Law, the Tack Endovascular System is Limited to
Investigational Use only, in the TOBA II (ATK) and TOBA II BTK studies.
Tack Endovascular System® and Tack® are registered trademarks of Intact Vascular, Inc.
The Tack Endovascular System® is CE Mark Authorized under EC Directive 93/42/EEC.
Not Available for sale or use in the United States.