The ACCESS-MANTA registry aims to assess and gather data on the contemporary on-label use of this device in standard-of-care transcatheter aortic valve replacement (TAVR) procedures.
The multicentre, international, observational, prospective and single-arm registry will enrol at least 250 patients in up to 15 key TAVR institutions across Canada and the US.
Its safety objective is defined by the Valve Academic Research Consortium-3 (VARC-3) for minor and major vascular complications related to the VCD large bore access site within 30 days of the TAVR procedure.
The effectiveness objective is defined by the time to haemostasis or the elapsed time between the deployment of the MANTA Device and the first observed and confirmed arterial haemostasis.
Furthermore, the trial will assess ambulation, technical, treatment success, procedure time and discharge readiness.
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Teleflex Interventional medical director Christopher Buller said: “Large bore access site complications are recognised as morbid, driving increased costs and prolonged length-of-stay.
“That is why percutaneous cardiac and peripheral procedures, such as TAVR, that are performed through large bore arteriotomies, need dedicated closure technology that is safe and effective as well as procedurally efficient.”
MANTA is claimed to be the first commercially available biomechanical VCD designed particularly for the closure of the large bore femoral arterial access site.
It received the CE mark in 2016 and the US Food and Drug Administration approval in 2019.