Teleflex gets premarket OK for biomechanical MANTA Closure
Teleflex Inc., a global provider of medical technologies for critical care and surgery, has announced that it received premarket approval from the U.S. Food and Drug Administration for the MANTA Vascular Closure Device – the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.
The MANTA Vascular Closure 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 U.S. 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.1 With its innovative design, the MANTA Device has the potential to reduce bleeding complications and offset other procedural costs.1
Zvonomir Krajcer, MD and the lead enroller and co-principal investigator of the SAFE MANTA IDE Clinical Trial and co-director of the Peripheral Vascular Disease Service at Texas Heart Institute in Houston, said he was very encouraged by the results of the SAFE MANTA IDE Clinical Trial. Dr. Krajcer is a consultant to Teleflex.
“The clinically proven major complication rate (as defined by the study protocol) of 5.3 percent and VARC-2 Major Vascular Complications rate of 4.2 percent 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.”
Greg Walters, co-inventor of the MANTA Device and now vice president of access and closure in the interventional business unit of Teleflex, said the 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 more than 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,” Walters said.
With the MANTA Device, clinicians and hospitals can achieve:
- Successful large bore closure with a device that is simple to use and does not require pre-closure, saving valuable time during the most delicate interventional procedures.
- Low complication rates for fast reliable biomechanical closure with rapid hemostasis, potentially reducing costs.1,2,3
- Reproducible results, inspiring confidence in achieving successful closure.1,4
Stewart Strong, president and general manager of the interventional business unit of Teleflex, said 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.” VTN
1Data on file at Teleflex. The SAFE MANTA IDE Clinical Trial:
2MANTA Device demonstrated a time to hemostasis of 24 seconds median time (65 seconds mean time) from deployment to hemostasis.
3Rate of time to hemostasis for MANTA Device demonstrated from deployment to hemostasis.
4Percutaneous vascular closure obtained with the MANTA™ Device without the use of unplanned endovascular or surgical intervention.