Teleflex’s Manta Device Receives FDA Premarket Approval for Large-Bore Femoral Arterial Access Site Closure
February 5, 2019—Teleflex Incorporated announced its Manta vascular closure device has received FDA premarket approval (PMA). The Manta device is the first commercially available biomechanical vascular closure device designed specifically for large-bore femoral arterial access site closure.
PMA was aided by recent data from SAFE MANTA IDE, a prospective, multicenter, single-arm clinical trial designed to evaluate large-bore femoral access site closure. SAFE MANTA IDE reported all primary and secondary endpoints were met and showed that the Manta device achieves fast, reliable biomechanical closure with rapid hemostasis.
“I am very encouraged by the results of the SAFE MANTA IDE clinical trial," said Zvonomir Krajcer, MD, lead enroller and Coprincipal Investigator of the SAFE MANTA IDE clinical trial, in the company's announcement. "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.” Dr. Krajcer is the Codirector of the Peripheral Vascular Disease Service at Texas Heart Institute in Houston, Texas.
According to Teleflex, the Manta device is indicated for closure of femoral arterial access sites while reducing time to hemostasis following the use of 10–20-F devices or sheaths (12–25-F outer diameter) in endovascular catheterization procedures, said the company.
Based on the SAFE MANTA IDE trial data, Teleflex noted the Manta device’s innovative design has the potential to reduce bleeding complications and offset other procedural costs. The company also highlighted that the device does not require preclosure, which can save valuable time for interventional procedures. In addition, low complication rates for fast reliable biomechanical closure with rapid hemostasis may reduce costs.