Eximo Medical, based in Israel, won FDA clearance for its B-Laser Atherectomy System that’s used to clear out plaque from within narrowed peripheral arteries, including in cases of in-stent restenosis. The laser operates at a 355nm wavelength, the only one of this kind, and the company believes that this wavelength has benefits over the commonly used 308nm excimer lasers. These include “safety, efficacy, cost and ease of use,” according to Yoel Zabar, CEO of Eximo Medical.
Here’s some data on the clinical trials performed using the B-Laser, as per Eximo:
Clinical evaluation of the B-Laser™ device in the intended population was performed in a prospective, single-arm, multi-center, open-label, non-randomized pilot clinical study in 50 subjects in Europe, as well as in a pivotal, prospective, single-arm, multi-center, open-label, non-randomized IDE clinical study in 97 subjects in U.S. and Europe.
In the pilot clinical study, the results presented 100% success in crossing the target with no device related perioperative clinically significant adverse events and no complications requiring intervention. There were no major adverse events (MAE) at one month and six months post procedure, and only two cases (4.3%) of TLRs among 46 subjects who completed the 1-year post procedure follow-up. In the pivotal study, the safety and efficacy primary endpoints were achieved with high margins and the 6-months data was consistent with the pilot study results.
Via: Eximo Medical…