Device profile of the tack endovascular system® for the treatment of peripheral arterial disease: overview of safety and efficacy

Abstract

ABSTRACT Introduction: The 6 F Tack Endovascular System® is approved by the United States Food and Drug Administration (FDA) for post-percutaneous transluminal angioplasty (PTA) dissection repair in the superficial femoral and proximal popliteal arteries, and the 4 F System for post-PTA dissection repair in the mid/distal popliteal, peroneal and tibial arteries. The latter is the first FDA approval for an infra-popliteal implantable device. Areas covered: An evaluation of the Tack Endovascular System® design and a summary of the current safety and efficacy data. Expert opinion: Endovascular intervention for the treatment of symptomatic peripheral arterial disease (PAD) in the lower extremities is complicated by long-lesion length, extensive calcification and, below the knee, narrow vessel diameter. PTA is a foundational element for the treatment of these lesions and works by causing a controlled dissection and vessel expansion of the target lesion. Occasionally, dissections can extend beyond the target lesion and/or become hemodynamically significant due to lumen impingement necessitating additional intervention. Historically these dissections were treated with the use of stents, prolonged balloon inflation time or went untreated. The Tack Endovascular System® was designed to provide operators a safe and effective device which could repair post-PTA dissections while preserving future treatment options.