Israeli tissue resection start-up, Eximo Medical Ltd. says it has received U.S. FDA 510(k) clearance for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD).
Background
B-Laser™ is described as a transformative 355nm wavelength laser technology designed to address unmet clinical needs for treating multiple vascular indications.
The specific indication cleared by the FDA is: “The B-Laser Atherectomy System is intended for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusion, including in-stent restenosis (ISR).”
This is the first solid-state, short pulse, 355nm laser system cleared in the U.S. for vascular interventions. The clearance represents a significant milestone for Eximo, as it can now offer the B-Laser™ Atherectomy System for PAD in the US.
Clearance follows two studies: In both the 50 patient pilot study and the 97 patient pivotal IDE study the safety and efficacy primary endpoints were achieved with high margins. 6-month data was consistent with the pilot study results.
Company comments
CEO of Eximo Medical, Yoel Zabar stated, “Based on its technical characteristics, preclinical and clinical results and physician feedback, it seems that this laser system provides significant advantages over traditional 308nm excimer laser systems in terms of safety, efficacy, cost and ease of use.”
He added, “We also plan to leverage our B-Laser™ platform technology to develop additional devices to address significant unmet needs in other vascular indications including lead extraction (for which we have completed a proof of concept), CAD, Thrombectomy and Venous Disease. Additionally, we are developing an add-on photo-acoustic monitoring tool and a disruptive medical device for interventional gastrointestinal procedures.”
Physician comments
“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 the national PI, Dr. John Rundback, Interventional Radiologist and Director of the Interventional Institute at Holy Name Medical Center, Teaneck, NJ. “The enrollment in both US and Europe was quick (6.5 months), and the study results up to six months, have been very impressive despite treating diverse lesions including calcium, thrombus, and restenosis including ISR, both above and below the knee.”
SAB member Dr. John Laird, Medical Director of the Adventist Heart and Vascular Institute said, “I have been extremely impressed with the results with the B-Laser™ Atherectomy System demonstrated in the clinical trials. 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.”
Source: Ronald Trahan Associates, Inc
published: October 11, 2018 in: Approval/Clearance, Clinical Studies/Trials, Vascular