Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser™ IDE study

Abstract

Background: The B-Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid-state Nd:YAG short pulse laser for de-novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque.

Methods: The study was a prospective, single-arm, multi-center, international, open-label study assessing the B-Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B-Laser™ catheter alone. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab.

Results: 97 (77 in USA) PAD subjects (51 male, mean 70.5 years [range 46-86]) with 107 lesions were treated with B-Laser™ (average length 5.4 cm [range 1-24], 29.0% infrapopliteal. 77.6% calcification [26.2% severe], 21.5% chronic total occlusions, 20.6% re-stenotic). Average reduction in residual stenosis post B-Laser™ alone was 33.6 ± 14.2%. Baseline and final stenosis (post laser and adjunctive therapy) were 85.7 ± 12.2% and 17.7 ± 11.0%, respectively. Duplex patency was 96.8% at 30-days and 85.6% at 6 months (95.7% 6-month patency with severe calcification), and did not differ between POBA vs. DCB sub-groups. ABI, Rutherford category and WIQ all improved. There was one MAE and three TLRs out of 101 lesions. No procedural distal embolization was noted and there were no major device-related dissections.

Conclusions: Experience with the B-Laser™ atherectomy system in infrainguinal PAD procedures demonstrates a high level of safety and efficacy for denovo and restenotic infrainguinal arterial lesions.

Keywords: clinical trials; laser; peripheral artery disease; peripheral atherectomy.