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Premarket Approval for MANTA™ Device for Closure of Femoral Arterial Access Sites
Teleflex Incorporated has received premarket approval (PMA) from the FDA for the MANTA Vascular Closure Device, designed specifically for the closure of large-bore femoral arterial access sites.
The device is indicated for closure of femoral arterial access sites while reducing time to hemostasis, after the use of 10–20F devices or sheaths (12–25F outer diameter [OD]) in endovascular catheterization procedures.
The SAFE MANTA IDE clinical trial, which is the largest U.S. prospective, multicenter, single-arm trial of a purpose-designed, large-bore femoral access site closure, demonstrated that the MANTA device achieves fast and reliable biomechanical closure with rapid hemostasis. All the trial’s primary and secondary endpoints were met.
Manta’s innovative design gives the it the potential to reduce bleeding complications and offset other procedural costs. It is simple to use and does not require pre-closure, which saves valuable time during delicate procedures. The clinically proven major complication rate of 5.3% and VARC-2 Major Vascular Complications rate of 4.2% compare very favorably to suture-mediated devices.
Source: Teleflex, February 4, 2019