The FDA cleared and CE certified B-Laser™ device's intended use and indication for use is similar to other approved atherectomy devices. Howvere, it is most innovative and has several differences compared to other devices. It is made of an array of optic fibers (to transfer laser energy) that are surrounded and supported by a circumferential blunt blade (for mechanical support and to complete the laser first cut). The catheter, which is made of known materials that are widely used in medical devices, is supplied sterile and intended for single use only. The B-Laser™ device performs partial removal of the lesion inside the artery, to improve the results of subsequent balloon angioplasty or stent placement in opening the blocked artery. Effective restoration of adequate blood supply is expected to decrease the pain in the leg.
The B-Laser™ solution- a single catheter that effectively treats all types of PAD lesions:
- Lesions inside stents
- Chronic total occlusions – defined as complete (100%) blockage of the artery
- Lesions with severe calcification
- Lesions which are made of thrombus (blood clots that blocks the artery)
- Lesions that are made of fibrotic and soft plaque
- Lesions located above the knee
- Lesions located below the knee and below the ankle
B-Laser™ bears the CE Mark and is FDA cleared.
B-Laser™ procedure duration is similar or less than the other non-surgical procedures to treat PAD.