Eximo Medical (Rehovot, Israel) has received U.S. FDA clearance for its B-Laser atherectomy system for peripheral artery disease (PAD). The system uses 355 nm laser technology to address unmet clinical needs for treating multiple vascular indications. The specific indication cleared by the FDA is for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusion, including in-stent restenosis (ISR).
The company also plans to leverage the system's technology, which uses optical fibers to deliver short laser pulses, to develop additional devices to address significant unmet needs in other vascular indications, including lead extraction, coronary artery disease (CAD), thrombectomy, and venous disease says Yoel Zabar, CEO of Eximo Medical. The company is also developing an add-on diagnostic tool and disruptive medical device for interventional gastrointestinal procedures, he says.
Clinical evaluation of the system in the intended population was performed in a prospective, single-arm, multicenter, open-label, non-randomized pilot clinical study in 50 subjects in Europe, as well as in a pivotal, prospective, single-arm, multicenter, 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 toll like receptors (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 six-month data was consistent with the pilot study results.
For more information, please visit www.eximomedical.com.