Eximo Medical have announced the first commercial use of their B-Laser atherectomy system for treatment of peripheral vascular disease. Barry Weinstock of Orlando Heart & Vascular Institute, director of the catheterisation laboratory at the Center for Cardiovascular Excellence in Orlando, USA used the B-Lase atherectomy aystem 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.
Weinstock commented, “Having participated in the US 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 embolisation 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 the Vascular Interventional Advances meeting (VIVA; 5–8 November, Las Vegas, USA) by John R Laird Jr, and at the Leipzig Interventional Course (LINC; 22–25 January, Leipzig, Germany) by Marianne Brodmann, and will be presented at several other meetings in 2019.
“Eximo’s US 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 embolisation (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 investigational device exemption study). Clinical outcomes at six months shows a high patency rate of 85.6% in general, and a very similar rate in the in-stent restenosis and chronic total occlusion sub-group, and an exceptional 95.7% patency at six 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 target lesion revascularisations observed in the studies which was three out of 141 subjects (2.1%),” said John Rundback, Teaneck, USA, the nominated principal investigator for the investigational device exemption 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 peripheral arterial disease.”