Presenter: Dr. Waclaw Kuczmik, Katowice, Poland. Clinical Experience with the innovative B-Laser™ for PAD.

Introduction: B-Laser™ (Eximo Medical, Israel), an innovative atherectomy system (small and mobile solid state Nd:YAG laser with disposable catheters), is a hybrid catheter (array of optical fiber emitting laser at 355nm with mechanical blunt blade). The catheter has 3-fold higher affinity for ablating lesions than endothelium and is indifferent to contrast media.

Materials & Methods: 27 PAD subjects (Rutherford 2-4) were enrolled with a total of 30 treated lesions. Calcification was seen in 26/30 (86.7%) and was graded as mild (6.7%), moderate (53.3%) or severe (26.7%). Twenty-two (73.3%) were CTOs and 1 was ISR. Average lesion length was 79.6mm. Locations were SFA (24/30), Popliteal (1/30), Femo/Popliteal (4/30) and tibial (1/30). Baseline stenosis, RVD, MLD, residual stenosis post B-Laser™ and post adjunctive therapy, and average reduction in stenosis post B-Laser™ were recorded. MAEs and perioperative complications were recorded.

Results: 100% success in crossing with the 1.5mm (24), 2mm (5) and 2.35mm (1) catheters. A single pass was in 22 lesions. There were no device related complications. EPD was used in only 4 cases. No MAEs nor TLRs were noted up to 6-months in 20 subjects so far, with 12-months data to follow. The baseline stenosis, RVD, MLD, residual stenosis post catheter, post adjunctive therapy and average reduction in residual stenosis post catheter were 96.8%±8.1, 4.47mm±1.31, 0.39±0.86 mm, 51.4%±24.7, 12.4%±13.6, and 45.4%±22.5.

Conclusion: Initial experience with the innovative B-Laser™ in PAD demonstrates excellent safety and performance results. Additional studies are planned.