09 Oct 2018
Eximo Medical’s B-Laser Atherectomy System treats Peripheral Artery Disease including ISR.Eximo Medical, based in Rehovot, Israel, has received 510(k) clearance from the US Food & Drug Administration (FDA) for its B-Laser™ Atherectomy System for Peripheral Artery Disease (PAD).
The 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 now approved 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.
“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 such as calcium, thrombus, and restenosis including ISR, both above and below the knee.”
First 355nm laser for this purpose
Yoel Zabar, CEO of Eximo Medical, commented, “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 US 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 technology to develop additional devices to address significant unmet needs in other vascular indications, including lead extraction, CAD, Thrombectomy and Venous Disease. We are also developing an add-on diagnostic tool and disruptive medical device for interventional gastrointestinal procedures.”
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 the US 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.
“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.
“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,” said SAB member Dr. John Laird, Medical Director of the Adventist Heart and Vascular Institute.
Narrowing or blockage of vessels that carry blood from the heart to the periphery is a common disorder, which can lead to post-narrowing/blockage ischemia. Peripheral artery disease affects over 12 million people worldwide and its prevalence is increasing as the population ages. People with PAD have a 2-6 times greater chance of death from heart attack or stroke hence improved diagnosis and management is critical.
Current treatment solutions include: surgical bypass, angioplasty and stenting, drug eluting balloons, and atherectomy. Recently, a laser-based atherectomy is gaining some market share. Eximo's proprietary, single-use catheter, B-Laser, which combines laser and mechanics, will turn atherectomy and the opening of in-stent stenosis into more effective and safer procedures.