Teleflex Commences Enrollment in ACCESS-MANTA Registry

November 16, 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 company’s Manta vascular closure device (VCD) in transcatheter aortic valve replacement (TAVR) procedures. The registry will include appropriate patient selection and proper vascular access.

According to the company, ACCESS-MANTA is an international, multicenter, prospective, observational, single-arm clinical registry. The primary objective is to evaluate the safety and effectiveness of the Manta VCD in TAVR procedures.

In the registry, safety is defined by VCD large-bore access-site–related Valve Academic Research Consortium-3 major and minor vascular complications within 30 days of the TAVR procedure. Effectiveness is 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.

At least 250 patients in up to 15 major TAVR institutions across the United States and Canada will be enrolled in the ACCESS-MANTA registry.

The study chair is George Dangas, MD. The study's principal investigators include Sahil Khera, MD, and Danny Dvir, MD.

Dr. Dangas is 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 in New York, New York. Dr. Khera is Interventional Director of the Structural Heart Program at Mount Sinai Hospital. Dr. Dvir is Director of Interventional Cardiology at Shaare Zedek Hospital Center in Jerusalem, Israel.

“We are excited that Mount Sinai Medical Center is spearheading the Teleflex ACCESS-MANTA Registry,” commented Dr. Khera in the company’s press release. “The study focuses on on-label use of the Manta device, appropriate patient selection using pre-TAVR CT imaging, and proper vascular access, all of which reflect the standard practice at our world-class, high-volume TAVR center. We look forward to this contribution to the advancement of large-bore access and closure.”

The Manta VCD is designed specifically for large-bore femoral arterial access site closure. The device received European CE Mark approval in 2016. In the United States, Manta VCD received FDA approval in 2019. It is available in 14- and 18-F sizes.

Manta is indicated for closure of femoral arterial access sites while reducing time to hemostasis after the use of 10- to 20-F devices or sheaths (12- to 25-F outer diameter) in endovascular catheterization procedures, advised Teleflex.