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Abstract
Purpose To test the feasibility of a novel microcatheter-deliverable self-expanding vascular plug for use in endovascular flow control and vessel occlusion.
Methods 40 peripheral vessels in 10 canines were utilised to assess acute technical feasibility and chronic in vivo performance of the Reverse Medical™ Corporation MVP™ Micro Vascular Plug System (MVP-3) compared to Covidien® Axium™ embolisation coils (5mm X 15cm helical) and St. Jude Medical® Amplatzer® Vascular Plug 4 (AVP-4 4mm x 10mm). In this study, arteries 1.5 - 3.0 mm in diameter were targeted for embolisation. Four vessel sites were chosen: left and right subclavian, and left and right internal thoracic arteries. Within each subject a single MVP-3 device was placed in three vessels and one control (a single AVP-4 or Axium coil) in the fourth vessel. Angiography was conducted 1,3,5 and 10 minutes post device implantation and a quantitative flow grade was given (TIMI Grade 0, 1, 2, or 3). If complete flow stasis (Grade 0) was achieved prior to 10 minutes, no further angiographies were performed for that vessel/device. Acute endpoints included system preparation, access, vessel embolisation and system performance/clinical acceptability. Post implantation each canine was given 80mg/day aspirin to create a worst-case recanalisation scenario. Chronic study endpoints include 1, 2, 3 and 6 months follow up for efficacy: patency, blood flow (occlusion), migration and re-canalisation; and safety: absence of adverse events associated with the device and/or delivery system, and histological and pathological evaluations including local foreign body reactions.
Results 40 target vessels, average diameter 2.55mm (range 1.86–2.89 mm), were successfully implanted with embolisation devices. MVP-3 devices and Axium coils were delivered through .021 microcatheter and AVP-4 devices were delivered through guide catheter. Flow reduction or occlusion within 10 minutes (TIMI Flow Grade 0, 1, or 2) was achieved 30/30 (100%) with a single MVP-3 device, versus 33% (2/6) with a single AVP–4 device, and versus 0% (0/4) with a single Axium Coil. Complete vessel occlusion was demonstrated in 17/30 (57%) target vessels with a single MVP-3 versus 0/6 (0%) for a single AVP–4 device vs 0/4 (0%) for a single Axium Coil. At 1, 2, 3 and 6 month follow up and histopathology, the MVP-3 had superior durability and neointimal coverage, less recanalisation compared to the control devices and demonstrated no migration.
Conclusions The novel MVP Micro Vascular Plug System demonstrated superior performance and clinical acceptability and provides for better occlusion/flow reduction compared to control devices.
Disclosures S. Tateshima: 2; C; Reverse Medical. 4; C; Reverse Medical. D. Niemann: 2; C; Reverse Medical. S. Moskowitz: 2; C; Reverse Medical. B. Baxter: 2; C; Reverse Medical. D. Frei: 2; C; Reverse Medical.