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.

Balloon Angioplasty of Infrapopliteal Arteries: A Systematic Review and Proposed Algorithm for Optimal Endovascular Therapy

“…112 Based on these results, laser atherectomy may have an additive beneficial effect in treating infrapopliteal lesions; however, the clinical efficacy and safety of each atherectomy technique for the treatment of infrapopliteal disease remains to be proven. [113][114][115] A subgroup analysis of only the patients with infrapopliteal disease from the prospective, multicenter DEFINITIVE LE (Determination of EFfectiveness of the SilverHawk PerIpheral Plaque ExcisioN System for the Treatment of Infrainguinal VEssels/Lower Extremities) trial (ClinicalTrials.gov identifier: NCT00883246) demonstrated that directional atherectomy prior to BTK angioplasty resulted in favorable clinical and technical results. 116 This study included 145 patients [70 claudicants (48.3%) and 75 patients with CLTI (51.7%)] with an average 58±44-mm lesion length.…”

“…112 Based on these results, laser atherectomy may have an additive beneficial effect in treating infrapopliteal lesions; however, the clinical efficacy and safety of each atherectomy technique for the treatment of infrapopliteal disease remains to be proven. 113–115…”

Tissue post‐classification using the measured acoustic signals during 355 nm laser atherectomy procedures

“…[ 1 ] Since then, a First in Man study (NCT02556255) including 50 subjects with a follow up of 1 year [ 2 ] and an IDE study, (NCT03157531) enrolling 97 Peripheral Artery Disease (PAD) patients (with a total of 107 lesions, 21.5% were chronic total occlusions [CTO]) treated with 355 nm laser atherectomy (Auryon, AngioDynamics Inc.), was conducted. The clinical results showed no major device‐related vascular complications requiring intervention in all patients with no emboli or perforations, [ 3, 4 ] and in the longer term, results showed excellent patency and clinical outcome at 6‐months [ 5 ] (with fluence of 50 or 60 mJ/mm 2 per pulse [ 2, 4 ] ). Thus, the initial first time 355 nm laser ablation that was found to have “tissue selectivity” in ex vivo model, showed in two clinical studies results that support the tissue selectivity by high‐safety profile with high efficacy, including in severe calcification.…”

“…Thus, the initial first time 355 nm laser ablation that was found to have “tissue selectivity” in ex vivo model, showed in two clinical studies results that support the tissue selectivity by high‐safety profile with high efficacy, including in severe calcification. [ 2, 4 ] The above tissue selectivity property is attributed to the photon energy of the 355 nm wavelength that is low enough to avoid photochemical reactions in blood vessels but is high enough to cause photochemical reactions in the lesion. Note, Severe calcification in the superficial femoral artery (SFA) is usually defined as involving more than 50% of the lesion length and visible on both sides of the treated artery.…”

“…This reaction creates a unique acoustic signature that depends on the tissue type, and enables to differentiate between the different tissue types (eg, occlusion versus artery). [ 13 ] The motivation for our work draws from the insight we gained when we were present in procedures of human atherectomy clinical trials, [ 2–4 ] whereby the human ear and brain could notice (to a certain extent) different sound signatures of lesion ablation versus nonlesion ablation.…”