Teleflex has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its Manta vascular closure device, which is designed specifically for large bore femoral arterial access site closure.
Teleflex stated that its Manta biomechanical 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 OD) in endovascular catheterization procedures.
The SAFE Manta IDE clinical trial, which was a multi-center, single-arm, purpose-designed trial for large bore femoral access site closure, showed that the device can offer fast and reliable biomechanical closure with rapid hemostasis, with all primary and secondary endpoints met.
The design of the device is claimed to have the potential to reduce bleeding complications and offset other procedural costs.
With the Manta device, the company claims that clinicians and hospitals can achieve large bore closures with the device, as it is claimed to be simple to use and does not require pre-closure. It can save valuable time during very delicate interventional procedures.
It can lower the rate of complications for fast and reliable biomechanical closure with rapid hemostasis and thereby reducing costs.
Manta Device co-inventor and Teleflex Access and Closure in the Interventional business unit vice president Greg Walters said: “Our team has been working hard to obtain FDA premarket approval and were confident they would recognize the benefits that the Manta Device can provide to the patient.
“We have had great success with the device in Europe over the last two years with over 10,000 units sold, and are thrilled to bring this innovative solution to patients in the U.S. and further fulfill this significant and previously unmet clinical need in the structural heart and endovascular space.”
Teleflex president and interventional business unit general manager Stewart Strong said: “Our commercial efforts in 2019 will include a measured launch of the Manta Device to ensure strong initial outcomes with key thought leading physicians as we further invest in building the commercial infrastructure to support the long-term growth of Manta Device revenues.”