1. Novel laser‐based catheter for peripheral atherectomy: 6‐month results from the Eximo Medical B‐Laser™ IDE study
- Author
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Ian Cawich, Gino Sedillo, Arthur Lee, Nicolas W. Shammas, Luis Mariano Palena, John H. Rundback, Chris Metzger, Antonio Micari, Pradeep Chandra, Marianne Brodmann, and Barry S. Weinstock
- Subjects
Male ,Atherectomy ,Time Factors ,medicine.medical_treatment ,Laser ,Lasers, Solid-State ,030204 cardiovascular system & hematology ,Lasers Solid-State ,Peripheral Arterial Disease ,03 medical and health sciences ,Clinical trials ,0302 clinical medicine ,80 and over ,Humans ,Medicine ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,030212 general & internal medicine ,Vascular Patency ,Target lesion revascularization ,Aged ,Aged, 80 and over ,Peripheral artery disease ,business.industry ,Ultrasound ,Peripheral atherectomy ,General Medicine ,Middle Aged ,medicine.disease ,United States ,Peripheral ,Europe ,Catheter ,Stenosis ,Treatment Outcome ,Atheroma ,Female ,Laser Therapy ,Cardiology and Cardiovascular Medicine ,business ,Nuclear medicine ,Clinical trials, Laser, Peripheral artery disease, Peripheral atherectomy, Aged, Aged, 80 and over, Atherectomy, Europe, Female, Humans, Laser Therapy, Lasers Solid-State, Male, Middle Aged, Peripheral Arterial Disease, Prospective Studies, Time Factors, Treatment Outcome, United States, Vascular Patency ,Calcification - 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
- Published
- 2019
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