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Teleflex TFX recently announced the enrollment of the first patient in the ACCESS-MANTA Registry. The international, multicenter, prospective, observational, single-arm clinical registry intends to examine and collect data on the outcomes of the contemporary on-label use of the MANTA Vascular Closure Device (“VCD”) in standard-of-care transcatheter aortic valve replacement (TAVR) procedures, including appropriate patient selection and proper vascular access.

The MANTA VCD — one of the primary product offerings of the company’s Interventional product category — is the first commercially available biomechanical VCD designed specifically for large-bore femoral arterial access site closure. The latest development comes as a boost for the segment.

Significance of the ACCESS-MANTA Registry

The ACCESS-MANTA Registry is set to enroll at least 250 patients in up to 15 major TAVR institutions across the United States and Canada. 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.

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The study will also evaluate technical success, treatment success, ambulation success, discharge readiness and procedure time. Since its first implantation in 2014, receiving its CE mark in 2016 and FDA approval in 2019, the MANTA Device has been well-studied in more than 10,000 patients and more than 70 publications.

News in Detail

Per TFX’s spokesperson, large-bore access site complications are recognized as morbid, driving increased costs and prolonged length of stay. Hence, percutaneous cardiac and peripheral procedures, such as TAVR, which are performed through large-bore arteriotomies, need dedicated closure technology that is safe, effective and procedurally efficient. The MANTA Device demonstrated these attributes in the pivotal SAFE MANTA IDE Clinical Trial — the largest prospective, multi-center study of a purpose-designed large-bore femoral arterial access site closure device to date in the United States.

However, the 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. Against this backdrop, the ACCESS-MANTA Registry will allow Teleflex to understand the degree to which these changes, coupled with a dedicated device that is optimally deployed, may improve large-bore outcomes.