No procedural distal embolization was noted and there were no major device-related dissections. There was one MAE and three TLRs out of 101 lesions. ABI, Rutherford category and WIQ all improved. Duplex patency was 96.8% at 30-days and 85.6% at 6 months (95.7% 6-month patency with severe calcification), and did not differ between POBA vs. Baseline and final stenosis (post laser and adjunctive therapy) were 85.7 ± 12.2% and 17.7 ± 11.0%, respectively. announced the first successful use of the company's B-Laser atherectomy system in a step-by-step approach (eg, crossing a noncrossable chronic total occlusion CTO cap without a guidewire) to treat patients with highly complex, arterial occlusive peripheral artery disease (PAD). Average reduction in residual stenosis post B-Laser™ alone was 33.6 ± 14.2%. 77.6% calcification, 21.5% chronic total occlusions, 20.6% re-stenotic).
Resultsĩ7 (77 in USA) PAD subjects (51 male, mean 70.5 years ) with 107 lesions were treated with B-Laser™ (average length 5.4 cm, 29.0% infrapopliteal. Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab. PRODUCT: Eximo Medical B-LaserTM for PAD of 5 Document number: EX-PAD-03 Revision: 02 6-Month Outcomes Analysis (from Day 36 to the end of study) The follow-up duration for each subject is 30-days post procedure for the primary and secondary endpoints, however subjects will be followed for 6-months post procedure. Cardiovascular death, major amputation, target lesion revascularization, WIQ, ABI and Rutherford class were obtained at baseline and out to 6 months. Primary core lab efficacy was mean reduction in diameter stenosis >20% by the B-Laser™ catheter alone. The study was a prospective, single-arm, multi-center, international, open-label study assessing the B-Laser™ in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. The B-Laser™ atherectomy system (Eximo Medical, Israel) is a 355 nm solid-state Nd:YAG short pulse laser for de-novo and restenotic infrainguinal PAD with enhanced affinity for atheroma and calcified plaque.