Data Presented From European Study of Eximo Medical’s B-Laser Atherectomy Catheter
November 8, 2018—John R. Laird Jr, MD, presented the European study data on Eximo Medical’s B-Laser atherectomy catheter at VIVA 2018, the Vascular Interventional Advances annual conference held November 5–8 in Las Vegas, Nevada.
Researchers set out to evaluate the B-Laser catheter for treatment of infrainguinal peripheral artery disease. In total, 53 lesions treated with the B-Laser were evaluated in 50 patients (38 men; mean age, 64 years) with Rutherford class 2 to 4 peripheral artery disease.
Calcification was seen in 88% of lesions and was graded as mild (27%) or moderate/severe (61%). Forty-three (78%) lesions were chronic total occlusions. Average lesion length was 7.4 cm; 45 of 53 (84.9%) lesions were in the superficial femoral artery, and eight (15.1%) were in the superficial femoral/popliteal artery, popliteal artery, and tibioperoneal trunk.
Clinical success was achieved in all 53 lesions. Researchers reported there were no perioperative device-related perforations, dissections, or distal embolizations, nor any other device-related complications.
Core lab evaluation of baseline stenosis, post–B-Laser and residual stenosis, and average reduction in residual stenosis after B-Laser use were 93.6% ± 13.6%, 58.7% ± 15.1%, and 35.04% ± 14.78%, respectively. Only two (2/46 [4.3%]) target lesion revascularizations were noted at 1-year follow-up.;
Based on these results, researchers concluded the B-Laser catheter is a promising technology for atherectomy of complex heterogeneous lesions and noted that additional research is ongoing.
According to the VIVA announcement, the B-Laser catheter is an atherectomy device that uses an array of optical fibers transmitting short (approximately 10 ns) pulses of 355-nm waves (small solid-state Nd:YAG laser) surrounded by a blunt blade. The catheter has a threefold higher affinity for ablation of fibrotic material than endothelium, is indifferent to contrast media presence, has aspiration (with the 2- and 2.35-mm catheters) and off-centering mechanisms (with the 2.35-mm catheter), and works efficiently in all types of lesions, including calcification.
Eximo Medical received FDA 510(k) clearance for the B-Laster atherectomy for use in peripheral artery disease in October.