FDA approves MANTA Vascular Closure Device for large bore femoral arterial access.- . Teleflex

Teleflex Incorporated has announced that it received premarket approval (PMA) from the FDA for the MANTA Vascular Closure Device � the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure. The MANTA� Vascular Closure Device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths (12-25F OD) in endovascular catheterization procedures. The SAFE MANTA IDE Clinical Trial, the largest US prospective multi-center, single-arm trial of a purpose-designed large bore femoral access site closure, demonstrated that the MANTA� Device successfully achieves fast reliable biomechanical closure with rapid hemostasis, with all primary and secondary endpoints met.1 With its innovative design, the MANTA� Device has the potential to reduce bleeding complications and offset other procedural costs.