Optimized drug-coated balloon angioplasty of the superficial femoral and proximal popliteal arteries using the Tack Endovascular System: TOBA III 12-month results
Journal of Vascular Surgery May 15, 2020
Brodmann M, Wissgott C, Brechtel K, et al. - Low-metallic content is combined with focal delivery to seal areas of dissection linked with balloon angioplasty in the Tack Endovascular System (Intact Vascular, Wayne, Pa). Researchers here examined the safety and effectiveness of the Tack Endovascular System in cases with dissections after drug-coated balloon (DCB) angioplasty. They conducted the Tack Optimized Balloon Angioplasty III (TOBA III) study, a prospective, multicenter, single-arm study, in which treatment was provided with Tack implants to cases who underwent percutaneous transluminal angioplasty with the Medtronic IN.PACT Admiral DCB (Medtronic, Dublin, Ireland) and experienced dissection after angioplasty. Enrollment of a total of 201 patients was done; of these, 169 had standard-length lesions (≥ 20 mm and ≤ 150 mm) and 32 had long-length lesions (>150 mm and ≤ 250 mm). Favorable safety and effectiveness results were observed when compared with historical benchmarks at 12 months in the standard-lesion cohort. Findings thus support safety and effectiveness of the Tack Endovascular System as a treatment option for patients with dissections after angioplasty in the superficial femoral and proximal popliteal arteries, with high patency, low rates of secondary intervention, and low incidence of bailout stenting when it is employed in combination with DCB.
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