LEO 7. Safety and Effectiveness of the Novel Temren Atherectomy System Combined Use With Extender Drug-Eluting Balloon in Lower Extremity Arteries
Objective
The objective of this study was to evaluate the novel Temren atherectomy system and Extender drug-eluting balloon (RD Global-Invamed, Ankara, Turkey) as percutaneous treatment of de novo and restenotic infrainguinal arterial lesions.
Methods
This prospective, single-center, nonrandomized investigational device exemption trial was conducted between August 2017 and February 2018. Patient enrollment was 67 patients (mean age, 63.2 years; 58% male) with 74 lesions (mean length, 36 mm; mean diameter stenosis, 87.2%). The primary efficacy end point, technical success, was the achievement of acute debulking with a postatherectomy residual diameter stenosis of 50% (before adjunctive therapy). The primary safety end point was the major adverse event (MAE) rate through 30 days.
Results
For the primary analysis, the rate of lesion technical success was 97.0%, meeting the prospectively established target performance goal of 86%. After postatherectomy adjunctive therapy, residual stenosis was 30% for 100% of lesions (mean final diameter stenosis, 10.9%). Improvement of Rutherford class occurred for 73% of patients through 30 days and for 81% through six months. MAEs were experienced by 8.9% (5/67) of patients through 30 days (meeting the target performance goal of <20%) and 12% through 6 months. Six-month freedom from target lesion revascularization and target vessel revascularization was 89.0% and 85.3%, respectively.
Conclusions
Based on the high rate of technical success and the low rates of MAEs through 6 months, the Temren atherectomy system and Extender drug-eluting balloon combined use is safe and effective for the debulking of lower extremity arterial lesions.
