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. The study chair is George Dangas, MD, PhD, Professor of Medicine (Cardiology), and Surgery, and the Director of Cardiovascular Innovation at the Zena and Michael A. Wiener Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai.

The principal investigators of the study include Sahil Khera, MD, Interventional Director of the Structural Heart Program at The Mount Sinai Hospital, and Danny Dvir, MD, Director of Interventional Cardiology at share Zedek Hospital Center, Jersualem. The MANTA? Vascular Closure Device is the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.4 Since the first implantation in 2014, receiving its CE mark in 2016, and FDA approval in 2019, the MANTA?

Device has been well studied in over 10,000 patients and in 70+ publications. Over 150,000 units have been sold globally. Available in 14 and 18 Fr.

sizes, the MANTA? Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20 Fr. devices or sheaths (12-25 Fr.

O.D.) in endovascular catheterization procedures. The technology creates an alternative to cut down and suture-mediated closure for large bore procedures and has proved useful in TAVI/TAVR, EVAR/PEVAR/TEVAR, and BAV.