Robert Giasolli

Early experimental and clinical experience with a focal implant for lower extremity post-angioplasty dissection.

OBJECTIVES This study provides preliminary data on the safety and feasibility of the use of a novel focal implant for managing post-percutaneous transluminal balloon angioplasty (post-PTA) dissection. BACKGROUND Post-PTA dissection of the lower extremity arteries is managed with stent placement. This provides an acceptable post-intervention result but has long-term disadvantages, such as in-stent restenosis. Focal treatment of post-PTA dissection and avoidance of stents are the objectives of the Tack-It (Intact Vascular, Inc., Wayne, Pennsylvania) device. METHODS A preclinical study and first-in-human data are presented. Seven swine underwent superficial femoral artery device placement, with a self-expanding nitinol stent on 1 side and a series of 4 Tack-It devices on the other side. Specimens were harvested at 28 days. The clinical study included 15 limbs that underwent revascularization for critical limb ischemia (n = 9) or claudication (n = 6). Twenty-five lesions were treated in the superficial femoral (n = 8), popliteal (n = 7), and tibial (n = 10) arteries. RESULTS The preclinical study demonstrated a reduction in stenosis with the Tack-It (16.8 ± 2.6%) compared with stents (46.4 ± 9.8%). Neointimal thickness and injury score decreased with the Tack-It. Clinically, Tack-It placement resulted in acute technical success with resolution of the post-PTA dissection in 100% of lesions. There were no device-related complications or major amputations. Eighteen of the 25 lesions were available for angiographic follow-up at 1-year, and patency was 83.3%. CONCLUSIONS Preclinical data suggest that the Tack-It device causes minimal vessel injury. Clinical use of the Tack-It to manage post-PTA dissection was safe and feasible in this early study and resulted in apposition of dissection flaps without stent placement.

A NOVEL ENDOVASCULAR NITINOL IMPLANT PROVIDES A MINIMALLY INJURIOUS STENT ALTERNATIVE FOR CREATING TISSUE APPOSITION: A 90-DAY FEMORAL ARTERY STUDY IN SWINE

The Tack-It Endovascular Stapler System™ is a novel metallic 6mm spot-treatment technology designed to create tissue apposition to treat local vascular dissections and decrease the risk of vascular injury through low outward radial force and minimal nitinol material in contact with the vessel