Teleflex announces first patient enrollment in ACCESS-MANTA™ registry

November 20, 2023- Teleflex Incorporated announced the first patient enrollment in a clinical registry that is intended to examine and collect data on outcomes of contemporary on-label use of the MANTA™ Vascular Closure Device (VCD) in standard of care transcatheter aortic valve replacement (TAVR) procedures. The registry will include appropriate patient selection and proper vascular access.

Enrolling at least 250 patients in up to 15 major TAVR institutions across the US and Canada, the ACCESS-MANTA Registry is an international, multicenter, prospective, observational, single-arm clinical registry. It will employ the primary objectives of safety, defined by VCD large bore access site-related Valve Academic Research Consortium-3 (VARC-3) major and minor vascular complications within 30 days of the TAVR procedure, and effectiveness, defined by time to hemostasis or the elapsed time between MANTA™ Device deployment and the first observed and confirmed arterial hemostasis.

The study will also evaluate technical success, treatment success, ambulation success, discharge readiness, and procedure time.

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