Intact Vascular’s Tack System Demonstrates Safety and Efficacy in Postapproval Clinical Use

 

October 29, 2019—Intact Vascular, Inc. announced findings from a single-center experience with the company’s Tack endovascular system for infrainguinal dissection repair. The study was published by Michael K.W. Lichtenberg, MD, et al online ahead of print in Journal of Endovascular Therapy.

The investigators reported on the practical experience with the Tack endovascular system at the Vascular Center Arnsberg, Klinikum Arnsberg in Arnsberg, Germany, after the company launched the device in Europe in January 2019.

According to Intact, the Tack dissection repair device was implanted in patients who underwent balloon angioplasty as part of endovascular revascularization for peripheral artery disease or critical limb ischemia and subsequently experienced postangioplasty dissection.

There were 63 dissections were evenly distributed above the knee (ATK) and below the knee (BTK) and exhibited characteristics representative of real-world clinical applications. Tack implants were deployed to treat 95.2% of these dissections, using the ATK system for femoropopliteal dissections and the BTK system for infrapopliteal dissections.

In the company’s announcement Dr. Lichtenberg, Chief of the Angiology Clinic and Venous Center at Klinikum Arnsberg, commented, “With a 98.3% technical success rate, this study demonstrates the practical application of the Tack implants in real-world lesions, completely resolving 59 of 60 dissections with no major adverse events and no device-related complications during the procedure.”

He added, “I am pleased with our experience using the Tack system, including cases with complex lesions. This technology is extremely impressive, and I look forward to continued use in my ATK and BTK treatment algorithms.”

 

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