Eximo Medical has secured 510(k) clearance from the US Food & Drug Administration (FDA) for its B-Laser atherectomy system to treat peripheral artery disease (PAD).
B-Laser is a 355nm wavelength laser technology developed for the treatment of multiple vascular indications, including in-stent restenosis (ISR).
The FDA’s approval allows B-Laser system for use in the treatment of atherectomy infrainguinal stenoses and occlusion, in addition to ISR.
B-Laser is an advanced single-use catheter that combines optical fibers to deliver short laser pulses, and also other innovative solutions for better results.
Eximo Medical CEO Yoel Zabar said: “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.
“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.”
B-Laser device was clinically assessed in a prospective, single-arm, multi-center, open-label and non-randomized pilot clinical study in 50 patients in Europe, as well as in IDE clinical study in 97 subjects in the US and Europe.
According to the company, the results showed 100% success in crossing the target with no device related perioperative clinically significant adverse events and no complications requiring intervention in the pilot clinical study.
The safety and efficacy primary endpoints have been achieved in the pivotal study, and the 6-months data was consistent with the pilot study results.
Adventist Heart and Vascular Institute medical director Dr John Laird 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.”
Eximo Medical is a startup Israeli firm, which developed a hybrid technology for better tissue resection in various vascular and gastrointestinal endoluminal applications.