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January 28, 2020

FDA Approves Larger Implant Size of Intact Vascular’s Tack Endovascular System

January 28, 2020—Intact Vascular, Inc. announced FDA premarket approval for the expansion of the company’s Tack endovascular system 6-F portfolio. The new 6-F system is indicated for repair of postangioplasty dissections in superficial femoral and proximal popliteal arteries ranging from 4 to 8 mm in reference vessel diameter, which allows for the treatment of a broader range of vessels compared to the current 6-F Tack implant offering.

According to the company, the 6-F Tack endovascular system was previously approved for use in superficial femoral and proximal popliteal arteries ranging in diameter from 3.5 to 6 mm for the repair of dissections after percutaneous transluminal balloon angioplasty. The Tack endovascular system provides a minimal metal approach for focal dissection repair of postangioplasty dissections to improve outcomes for patients with peripheral artery disease.

In the company’s press release, Michael K.W. Lichtenberg, MD, commented, “The Tack system performs exceptionally well when repairing dissections, which are a common occurrence following balloon angioplasty in patients with peripheral arterial disease. The clinical benefit of Tack implants is clear and proven as demonstrated in multiple clinical trials, peer-reviewed publications, and real-world experience. I am pleased to have a larger size implant available, giving me even greater flexibility when treating larger SFA vessels.” Dr. Lichtenberg is Chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Arnsberg, Germany.

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