Eximo Medical recently announced that it has received FDA 510(k) clearance for its B-Laser Atherectomy System that is designed for peripheral artery disease.
The B-Laser system is a 355nm wavelength laser that is designed to treat multiple vascular issues. The system has been cleared for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusion, as well as in-stent restenosis, according to the company.
“This clearance represents a significant milestone for Eximo, as we can now offer the B-Laser Atherectomy System for PAD in the US. This is the first 355nm laser system cleared in the U.S. for this purpose and, according to the clinical results and the feedback that we received from physicians, it seems that this wavelength provides significant advantages over traditional 308nm excimer lasers in term of safety, efficacy, cost and ease of use,” said Yoel Zabar, CEO of Eximo Medical. “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 diagnostic tool and disruptive medical device for interventional gastrointestinal procedures.”