Nakamura K; Bailey L; Grintz T; Keating JH; Edelman ER. ‘Efficacy and Histomorphologic Evaluation of the Essential Medical MANTA Large Bore Vascular Closure Device in Swine.’

Background: Vascular access site complications are a significant source of morbidity following percutaneous catheterization, particulary for interventions requiring large bore cannulation such as transcatheter aortic valve replacement (TAVR). The benefit of vascular closure device (VCD) over manual compression is most pronounced for large bore access and higher baseline risk. The Essential Medical MANTA VCD utilizes a collagen implant secured by intraluminal anchor and is specifically designed for large bore cannulation.

Methods: Three Yorkshire swine underwent surgical laporotomy to expose the abdominal aorta. Three 18 French vascular access sites were obtained in each animal and closed with the MANTA VCD. Angiography was performed on Days 0, 15 and prior to necropsy. Limited necropsy was performed at Days 30, 90, and 180 for histomorpholoigcal analysis.
Results: All nine MANTA VCD achieved patent hemostasis on first attempt as assessed by gross inspection and angiography. Serial histomorpholoigcal analysis revealed complete dissolution of implant collagen and presence of neointimal endothelialization of the prosthetic anchor by Day 90 day. (Figure). Histological evidence of thrombosis was minimal at Day 30 and subsequently absent therafter, and neointimal or advential fibrosis was minimal at all timepoints. There was no evidence of vascular occlusion or other complication at anytime.

Conclusions: The MANTA VCD successfully closed large bore arerial access in swine without complication and favorable healing characteristics as assessed by serial histomorphology. The MANTA is a promising platform for rapid, effective, and safe arterial closure.

Podium presentation at: Innovations in Cardiovascular Interventions (ICI); Dec 13-15; Tel Aviv, Israel.