Teleflex Receives Health Canada Approval Of MANTA Vascular Closure Device

(RTTNews) - Medical technologies firm Teleflex Inc. (TFX) announced Wednesday that it received Health Canada approval for the MANTA Vascular Closure Device, the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.

This approval marks an important milestone in the regulatory plan to expand the availability of the MANTA Device globally and provides access to another uniquely designed device from Teleflex to Canadian clinicians.

Available in 14 Fr. and 18 Fr., the MANTA 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 North American 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.