Eximo Medical Launches B-Laser Atherectomy System

 

January 28, 2019—Eximo Medical Ltd. announced the launch and first commercial use of its B-Laser atherectomy system for treatment of peripheral vascular disease.

Barry Weinstock, MD, who is with Orlando Heart & Vascular Institute and Director of the catheterization laboratory at the Center for Cardiovascular Excellence in Orlando, Florida, used the B-Laser atherectomy system to successfully treat a patient with severe in-stent restenosis in the superficial femoral artery as well as a critical de novo stenosis in the proximal popliteal artery.

Dr. Weinstock commented in the company's announcement, “Having participated in the United States study as an investigator and seen the impressive efficacy and safety data Eximo’s B-Laser system was able to generate in a wide variety of challenging lesions, I was extremely excited to perform the first commercial procedure. Beyond the impressive clinical and safety data, I found the system to be far smaller, has virtually no warm-up time, and is more convenient than competitive systems. The B-Laser system’s ability to lase in blood with contrast media significantly enhances ease of use and helped speed up case time. Also, the built-in aspiration feature virtually eliminated any risk of distal embolization and allowed me to complete the case without the use of additional embolic protection. Best of all, we achieved remarkable debulking of both lesions using one pass with a single catheter. I was able to treat both lesions in only a few minutes and the intervention was easily completed with adjunctive [drug-coated] balloon angioplasty.”

John R. Laird Jr, MD, presented the European study data on the B-Laser atherectomy catheter at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada. Prof. Marianne Brodmann also presented the B-Laser clinical data at LINC, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany. Data will be presented at additional conferences this year.

“Eximo’s United States pivotal data from 147 patients showed average reduction of some 34% from a fairly high baseline residual stenosis, without any complications requiring intervention and no distal embolization (verified by core lab) with only eight embolic protection devices used (six at initial phase of the CE study and only two at the beginning of the IDE study), stated John Rundback, MD, who serves as the National Principal Investigator for the investigational device exemption (IDE) study of the B-Laser device. "Clinical outcomes at 6 months show a high patency rate of 85.6% in general, a very similar rate in the in-stent restenosis and chronic total occlusion subgroup, and an exceptional 95.7% patency at 6 months in the subgroup of severely calcified lesions, which accounted for 26% of all patients in the studies. This data coincides nicely with the very low rate of target lesion revascularizations observed in the studies, which was three out of 141 subjects (2.1%). I am looking forward to my first commercial use of the B-Laser system very soon, and as the Lead Clinical Investigator in the pivotal study, I believe this technology has the potential to usher in a new era in arterial prep for peripheral artery disease.”

 

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