Eximo Medical, a small Israel-based medical device maker, on Monday announced it received FDA 510(k) clearance for its B-Laser single-use atherectomy system for treating peripheral artery disease (PAD).

The device is the first 355 nm laser system cleared in the United States for PAD and is designed to address unmet clinical needs for multiple vascular conditions, the company said. The system was approved for the treatment of infrainguinal stenoses and occlusion, including in-stent restenosis (ISR).
Eximo said it intends to leverage the technology to develop additional devices for other vascular indications, including lead extraction, coronary artery disease, thrombectomy and venous disease.

The market for treatments to address PAD continues to attract new entrants as the global prevalence of the disease increases. The condition, which is most common in the legs, is characterized by narrowing of the blood vessels primarily due to the buildup of fatty plaque. More than 200 million people worldwide are estimated to have the disease, including 8 million in the United States, according to the American College of Cardiology.

The Eximo Medical B-Laser uses optical fibers that deliver short pulses in a catheter-based procedure to dissolve the lesion inside an artery before balloon angioplasty or stent placement. The company said the 355 nm wavelength provides advantages over traditional 308 nm lasers in safety, effectiveness and ease of use.

The device was evaluated in a single-arm, multi-center, open-label, non-randomized pilot study of 50 patients in Europe, and in a pivotal, single-arm, multi-center, open-label, non-randomized investigational device exemption study in 97 subjects in the United States and Europe. Safety and efficacy primary endpoints were met with high margins in the pivotal study, the company said.

"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," John Rundback, primary investigator and director of the interventional institute at Holy Name Medical Center in Teaneck, N.J., said in a press release.

In addition to developing devices for other vascular indications, Eximo Medical said it is working on an add-on diagnostic tool and a device for gastrointestinal procedures.

FDA recently released draft guidance for companies making 510(k) submissions for peripheral vascular atherectomy devices covering the four main categories of the devices: directional, rotational, orbital and laser.