157 0 Kommentare Teleflex Announces First Patient Enrollment in ACCESS-MANTA Registry

Registry Intends to Examine Contemporary On-Label Use of the MANTA Vascular Closure Device Including Appropriate Patient Selection and Proper Vascular Access

WAYNE, Pa., Nov. 16, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today 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.

“Large bore access site complications are recognized as morbid,¹ driving increased costs and prolonged length-of-stay,²” said Teleflex Interventional Medical Director, Christopher Buller, MD. "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.”

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“The MANTA Device demonstrated those attributes in the pivotal SAFE MANTA IDE Clinical Trial,³” Dr. Buller added. “However, TAVR practice has since evolved to embrace routine access site imaging, awake procedures, somewhat smaller delivery systems and sheaths, lower-risk patients, and considerably higher per-operator experience. The ACCESS-MANTA Registry will allow us to understand the degree to which these changes, coupled with a dedicated device that is optimally deployed, may improve large bore outcomes.”

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