Intact Vascular has announced US Food and Drug Administration (FDA) pre-market approval (PMA) for the expansion of its Tack Endovascular System (6F) portfolio. The new approved device size is indicated for repair of post-angioplasty dissections in superficial femoral and proximal popliteal arteries ranging from 4–8mm reference vessel diameter, allowing treatment of a broader range of vessels compared to the current 6F Tack implant offering.
“The Tack System performs exceptionally well when repairing dissections, which are a common occurrence following balloon angioplasty in patients with peripheral arterial disease,” commented Michael KW Lichtenberg, chief of Angiology Clinic and Venous Center, Klinikum Arnsberg in Arnsberg, Germany. “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.”
Arterial dissections are a frequent consequence of balloon angioplasty and can compromise clinical outcomes, leading to acute thrombosis and occlusions. These complications lower long-term patency rates and result in repeat procedures, limiting future treatment options. A first-of-its-kind, minimal metal approach for focal dissection repair, the Tack Endovascular System, repairs post-angioplasty dissections to improve outcomes for patients with peripheral arterial disease (PAD).
“Being able to provide the Tack implant in sizes up to 8mm is an important product offering for our customers,” remarked Steve MacKinnon, vice president of sales for Intact Vascular. “We are excited to bring a full range of implant sizes to market and further improve outcomes for endovascular interventions.”