Premium
Novel laser‐based catheter for peripheral atherectomy: 6‐month results from the Eximo Medical B‐Laser™ IDE study
Author(s) -
Rundback John,
Chandra Pradeep,
Brodmann Marianne,
Weinstock Barry,
Sedillo Gino,
Cawich Ian,
Micari Antonio,
Lee Arthur,
Metzger Chris,
Palena Luis Mariano,
Shammas Nicolas W.
Publication year - 2019
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.28435
Subject(s) - medicine , stenosis , atherectomy , target lesion , calcification , restenosis , revascularization , radiology , surgery , stent , myocardial infarction , percutaneous coronary intervention
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.