Eximo laser
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Characteristics are displayed in Table 1. The “B-Laser™ Atherectomy System” is based on a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm and short pulses at 40 Hz.
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1) and that was cleared by FDA following the results of this study. The “B-Laser™” (Eximo Medical, Israel) is a novel atherectomy device that was investigated in the United States (Fig. The use of Excimer laser has also been shown to improve patency and target lesion revascularization at 1 year in treating in-stent restenosis when compared to balloon angioplasty. These debulking devices improve vessel compliance and therefore reduce dissections and bail out stenting.
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There are several atherectomy devices on the market including rotational (Jetstream, Rotablator, Phoenix ), ablative (Excimer laser ), directional (SilverHawk/TurboHawk ) and orbital (Diamondback ). There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up.Ītherectomy is an established technique to treat denovo obstructive disease in infrainguinal arteries. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ± 14.2% meeting the primary efficacy endpoint goal. Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. The mean percent stenosis at the target lesion as assessed by the Core lab was 85.7% ± 12.2 (femoro-popliteal 85.6 ± 12.8% tibials 86.0 ± 9.6%). Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). Mean lesion length was 53.96 ± 43.18 mm and 26.2% had severe calcification. Mean age was 70.5 years and 51% were males. A total of 97 subjects (107 lesions) were enrolled.