![]() 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. The primary safety endpoint was freedom from major adverse events (MAEs) defined as: unplanned target limb amputation above the ankle, clinically driven target lesion revascularization (CD-TLR) and cardiovascular related death.Ī total of 97 subjects (107 lesions) were enrolled. The primary efficacy endpoint was the average reduction in residual diameter stenosis of >20% from baseline prior to any adjunctive therapy achieved by the B-Laser™ catheter alone. The study enrolled patients in the United States and Europe. ![]() #WWW EXIMO DE TRIAL#pivotal trial of the EXIMO B-Laser™.ĮX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. We present the results of the EX-PAD-03 U.S. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. ![]()
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