Eximo Medical Gains FDA Clearance for B-Laser Atherectomy System

October 16, 2018—Eximo Medical Ltd announced that its B-Laser atherectomy system has received FDA 510(k) clearance for use in peripheral artery disease. The cleared indication for the 355-nm wavelength B-Laser encompasses the treatment, including atherectomy, of infrainguinal stenoses and occlusions, as well as in-stent restenosis (ISR).

The Israel-based company described the clinical evaluation of the B-Laser as being performed in a prospective, multicenter, single-arm, open-label registry of 50 subjects in Europe, as well as a pivotal, prospective, single-arm, multicenter, open-label investigational device exemption study of 97 patients in the United States and Europe. Data from these experiences include 100% success in crossing the target lesion, with no clinically significant device-related perioperative adverse events and no complications that required intervention.

No major adverse events were noted at 1- and 6-month follow-up in the pilot study; among 46 patients reaching 1-year follow-up, two cases required target lesion revascularization. The company notes that in the pivotal study, the primary safety and efficacy endpoints were met high margins, and the 6-month data are consistent with results seen in the pilot study.

Commenting in Eximo's announcement were John Rundback, MD, who serves as National Principal Investigator, as well as Kenneth Rosenfield, MD, and John Laird, MD.

"I used the B-Laser in challenging procedures during the pivotal study and found the device easy to set up and use, and a valuable addition to our treatment portfolio," said Dr. Rundback, an interventional radiologist and Director of the Interventional Institute at Holy Name Medical Center, Teaneck, New Jersey. "The enrollment in both US and Europe was quick (6.5 months), and the study results up to 6 months have been very impressive despite treating diverse lesions including calcium, thrombus, and restenosis including ISR, both above and below the knee."

"After working with Eximo and watching their unique technology mature over several years, it is exciting to see their B-Laser system achieve such positive results in a rigorous clinical trial, and to obtain FDA 510(k) clearance as a result," commented Dr. Rosenfield, Section Head for Vascular Medicine and Intervention at Massachusetts General Hospital in Boston, Massachusetts. "This user-friendly, compact and versatile therapeutic system, with indications for essentially all lesion subsets below the inguinal ligament, represents a significant advance and provides a new tool to help optimize results for our patients. I look forward to the development of many other applications for this unique laser system, which appears to have a superb safety and efficacy profile."

"I have been extremely impressed with the results with the B-Laser atherectomy system demonstrated in the clinical trials," said Dr. Laird, Medical Director of the Adventist Heart and Vascular Institute in St. Helena, California. "The excellent safety profile combined with extremely low need for repeat procedures make this a very promising alternative for our patients with complex vascular disease."