Balloon Angioplasty for Limb Salvage in Occlusive Tibioperoneal Arterial Disease. Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer laser randomized controlled study for treatment of FemoropopliTEal in-stent restenosis). Directional Atherectomy followed by a paclitaxel-coated balloon to inhibit restenosis and maintain vessel patency: twelve-month results of the DEFINITIVE AR study. Critical limb ischemia: an expert statement. Superficial femoral artery intervention: creating an algorithmic approach for the use of old and novel (endovascular) technologies. ![]() No procedural distal embolization was noted and there were no major device-related dissections.Įxperience with the B-Laser™ atherectomy system in infrainguinal PAD procedures demonstrates a high level of safety and efficacy for denovo and restenotic infrainguinal arterial lesions.Ĭlinical trials laser peripheral artery disease peripheral atherectomy. 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. 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). ![]() Duplex ultrasound patency (PSVR <2.5), was evaluated by Core Lab.ĩ7 (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. 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. Sealed Blast Gate Code BGS (to 200mm diameter) Dimensional Specifications Dimensional specifications are given in the table below 4.
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