B-Laser^TM Atherectomy System for Infrainguinal Arteries. A Novel Technology for PAD and Beyond

B-Laser^TM Atherectomy system is an innovative single-use catheter made of an array of optic fibers and surrounded and supported by a circumferential blunt blade. It has CE Mark and 510(k) and is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions, including In-Stent Restenosis (ISR). The catheter can effectively and safely treat any type of lesion including CTOs, severely calcified, soft, fibrotic, thrombotic and ISR, both ATK, and BTK. The device was evaluated in two studies enrolling 147 subjects (163 lesions) and currently is in a commercial phase in the US. The B-Laser^TM clinical studies data (published) shows superb efficacy and safety, verified by independent core-lab, and repeat same results in the commercial phase so far. The device has zero complications requiring intervention, zero perforation, zero emboli (with only a few EPDs used) and no flow-limiting dissections post balloon in the B-Laser^TM treated areas. Average debulking is 34% and general primary patency by duplex (<2.5) at 6 months is 86%, for severely calcified lesions is 96% and for ISR is 87%. Similar primary patency at 6 months is similar between POBA and DCB subgroups. TLR rate at 6 months is 1.9%, and at 12 months is 4.3%, both are much lower than similar studies with other atherectomy devices. None of the TLR was ISR. Recently highly calcified lesions were atherectomized safely and successfully in CTO without a guidewire. Future PMS are planned. Future indications include coronary atherectomy, lead extraction, and all types of venous thrombectomy.