REHOVOT, Israel--(BUSINESS WIRE)--Eximo Medical Ltd., announced today the successful launch and first commercial use of the B-Laser™ Atherectomy System for treatment of peripheral vascular disease. Dr. Barry Weinstock of Orlando Heart & Vascular Institute, 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, “Having participated in the U.S. 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 eluting balloon angioplasty.”
The company’s clinical data was recently presented at VIVA 2018 by Dr John R. Laird Jr, MD, and at LINC 2019 by Prof. Marianne Brodmann, and will be presented at ISET 2019, Euro-PCR 2019 and CRT 2019 by Dr. Ken Rosenfield, Dr. Paolo Sbarzaglia and Dr. Nick Shammas.
“Eximo’s U.S. 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 8 embolic protection devices used (6 at initial phase of the CE study and only 2 at the beginning of the IDE study). Clinical outcomes at 6 months shows a high patency rate of 85.6% in general, and a very similar rate in the ISR and CTO sub group, and an exceptional 95.7% patency at 6 months in the sub-group of severely calcified lesions which accounted for 26% of all patients in the studies. This data coincides nicely with the very low rate of TLRs observed in the studies which was 3 out of 141 subjects (2.1%),” said Dr. John Rundback, Teaneck, NJ, the NPI for the IDE study, “and 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 PAD.”
Eximo Medical recently appointed Robert (Bob) Spanos, as its VP of US Sales Accounts.
About Eximo Medical Ltd.
Eximo Medical is an Israeli startup company with novel hybrid technologies for tissue resection in various vascular and gastrointestinal endoluminal applications.