Novel laser-based catheter for peripheral atherectomy: 6-month results from the Eximo Medical B-Laser IDE study
Catheterization and Cardiovascular Interventions Aug 21, 2019
Rundback J, Chandra P, Brodmann M, et al. - In this prospective, single-arm, multi-center, international, open-label study, researchers evaluated the B-Laser atherectomy system in symptomatic (Rutherford 2 to 4) infrainguinal peripheral artery disease. With 107 lesions, 97 (77 in USA) PAD individuals (51 male, mean 70.5 years [range 46–86]) were treated with B-Laser. The average reduction in residual stenosis after B-Laser alone was estimated to be 33.6 ± 14.2%. At 30-days and at 6 months, the Duplex patency was estimated to be 96.8% and 85.6%, respectively. Improvements were seen in ABI, Rutherford category and WIQ. They found no procedural distal embolization and no major device-related dissections. Overall, a high level of safety and efficacy was reported in correlation with the use of B-Laser atherectomy system in infrainguinal PAD procedures for denovo and restenotic infrainguinal arterial lesions.
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