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
; 21(1): 86-92, 2020 01.
Article
in En
| MEDLINE
| ID: mdl-30559030
ABSTRACT
BACKGROUND:
B-Laser™ is a novel atherectomy device that uses a solid-state third harmonic pulsed NdYAG laser with an output of 355â¯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™.METHODS:
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.RESULTS:
A total of 97 subjects (107 lesions) were enrolled. Mean age was 70.5â¯years and 51% were males. Diabetes mellitus was present in 42.3%. Mean lesion length was 53.96⯱â¯43.18â¯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%⯱â¯12.2 (femoro-popliteal 85.6⯱â¯12.8%; tibials 86.0⯱â¯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%⯱â¯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⯱â¯0.18), Rutherford category (-1.79⯱â¯1.22) and WIQ (0.26⯱â¯0.28) were noted at 1â¯month. There was no target lesion revascularization and the patency was 96.8% by duplex ultrasound criteria at 30-day follow up.CONCLUSION:
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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Atherectomy
/
Lasers, Solid-State
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Peripheral Arterial Disease
/
Vascular Calcification
Type of study:
Clinical_trials
/
Etiology_studies
/
Observational_studies
/
Risk_factors_studies
Limits:
Aged
/
Aged80
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
America do norte
/
Europa
Language:
En
Journal:
Cardiovasc Revasc Med
Journal subject:
ANGIOLOGIA
/
CARDIOLOGIA
Year:
2020
Document type:
Article