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SHR Neuro Cancer Cardio Lipid Metab Microb
Shammas, NW; Chandra, P; Brodmann, M; Weinstock, B; Sedillo, G; Cawich, I; Micari, A; Lee, A; Metzger, C; Palena, LM; Rundback, J; EX-PAD-03 Investigators.
Acute and 30-Day Safety and Effectiveness Evaluation of Eximo Medical's B-Laser™, a Novel Atherectomy Device, in Subjects Affected With Infrainguinal Peripheral Arterial Disease: Results of the EX-PAD-03 Trial.
Cardiovasc Revasc Med. 2020; 21(1):86-92
Doi: 10.1016/j.carrev.2018.11.022
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- Co-authors Med Uni Graz
- Brodmann Marianne
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- Abstract:
- B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed Nd:YAG laser with an output of 355 nm. Early data showed that the B-Laser™ is safe in treating a broad range of infrainguinal arterial lesions. We present the results of the EX-PAD-03 U.S. pivotal trial of the EXIMO B-Laser™. EX-PAD-03 is a prospective, single-arm, multi-center, international, open-label, clinical study. The study enrolled patients in the United States and Europe. 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 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. A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5 years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96 ± 43.18 mm and 26.2% had severe calcification. Lesions were de novo (79.4%), followed by in-stent restenosis (ISR) (15.9%) and non in-stent restenosis (4.7%). 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%). Post B-Laser™ and prior to adjunctive therapy, the mean percent stenosis at the target lesion was 52.1%. This resulted in a mean reduction from baseline to post B-Laser™ of 33.6% ± 14.2% meeting the primary efficacy endpoint goal. The freedom from MAE through the 30-day follow-up period after intervention was 98.9%. Per Core lab, there was no device-related distal embolization, dissections that required additional therapy, perforation, or pseudoaneurysm. Bailout stenting was 0.9%. A significant improvement from baseline in ABI (0.24 ± 0.18), Rutherford category (-1.79 ± 1.22) and WIQ (0.26 ± 0.28) were noted at 1 month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up. The Eximo B-Laser™ is effective and safe in ablating atherosclerotic and restenotic tissue for both above and below the knee obstructive arterial disease. The device has a high safety profile including a low risk of distal embolization. Copyright © 2018 Elsevier Inc. All rights reserved.
- Find related publications in this database (Keywords)
- Laser
- Solid-state laser
- Peripheral arterial disease
- Distal embolization
- Denovo disease
- Restenosis
- Aspiration
- Calcified lesions
- In-stent restenosis