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 of the SAFE MANTA IDE Clinical Trial. The clinically proven major complication rate (as defined by the study protocol) of 5.3% and VARC-2 major vascular complications rate of 4.2% compare very favorably to suture mediated devices and the 24 second median time (65 second mean time) from deployment to hemostasis was impressive. We have been patiently waiting for this approval, are eager to use the Manta Device commercially and look forward to the efficiencies it can provide,” co-principal investigator Dr. Zvonomir Krajcer of Houston’s Texas Heart Institute said in a prepared statement.
“FDA premarket approval is another important milestone for the Manta vascular closure device. 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,” prez & interventional biz unit GM Stewart Strong said in prepared remarks.
Last November, Teleflex reported third-quarter earnings that topped the consensus on Wall Street and raised its earnings outlook for the rest of the year, sending share prices up.