Final stenosis post-percutaneous transluminal angioplasty (PTA) was 17.7 +/- 11.0%. Most patients (73.8%) had femoral lesions. About 68% were Rutherford Class 3 or 4, 82.9% had an ankle-brachial index (ABI) <0.9 (average ABI 0.7), and 85.2% had a Walking Impairment Questionnaire (WIQ) score <39 (average WIQ score 22.8). Large majorities had hypertension (91.8%), dyslipidemia (85.6%) and/or were current or prior smokers (80.4%). The primary safety endpoint was major adverse events, a composite of cardiovascular death, amputation above the angle or clinically driven target lesion revascularization (CD-TLR), at 30 days.Ī total of 97 patients (51 male, 46 female) were enrolled. The primary effectiveness endpoint was general average reduction in residual diameter stenosis >20% from baseline prior to any adjunctive therapy achieved by the B-Laser catheter alone. Shammas, MD, MS, FACC, FSCAI, president and research director of the Midwest Cardiovascular Research Foundation.
Rutherford Class 2-4 patients were included in the study if they had an infrainguinal lesion ≥70% in a native artery and excluded if the lesion length was >15 cm (though ISR lesions were allowed up to 25 cm), said Nicolas W. The B-Laser (Eximo Medical Ltd., Rehovot, Israel) is a solid-state short-pulsed (10-25 ns) 355 nm wavelength laser used above and below the knee, including the treatment of calcified lesions, in-stent restenosis (ISR) and chronic total occlusions.ĮX-PAD-03 is a prospective, single-arm, multicenter, multinational clinical study with the objective of assessing the safety and efficacy of the laser in patients with infrainguinal peripheral artery disease.
#Eximo laser trial#
The Eximo Medical B-Laser is safe and effective at reducing residual diameter stenosis in all infrainguinal lesion subtypes, according to late-breaking trial results presented Tuesday at Cardiovascular Research Technologies (CRT) 2019.
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