Teleflex wins FDA PMA for Manta large bore vascular closure device

Teleflex (NYSE:TFX) said today that it won FDA premarket approval for its Manta vascular closure device, touting it as the first such device specifically designed for large bore femoral access site closures. The newly cleared Manta device won indications for closing femoral arterial access sites while reducing time to hemostasis following the use of 10-20F devices or sheaths in endovascular catheterization procedures, the Wayne, Penn.-based company 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,” device co-inventor & acess and closure division VP Greg Walters said in a press release. Clearance of the device came supported by data from the SAFE MANTA IDE clinical trial of the device, which Teleflex touted as the largest US prospective multi-center, single-arm trial of such a large bore femoral access site closure device. Results from the trial, which met its primary and secondary endpoints, indicated that the Manta device was able to produce fast reliable biomechanical closure and rapid hemostasis. “I am very encouraged by the results o...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Vascular Teleflex Source Type: news