Teleflex wins Health Canada approval for Manta vascular closure device

ByLance T. Lee

May 18, 2022

Teleflex (NYSE: TFX) today announced that its Manta vascular closure device has received Health Canada approval.

Teleflex, based in Wayne, Pennsylvania, designed the Manta biomechanical vascular closure device for large-bore femoral arterial access site closure.

“Our team worked diligently to obtain this approval and were confident that Health Canada would recognize the benefits of the Manta device,” said Scott Holstine, President and General Manager of Teleflex’s Interventional Business Unit. “We have had great success with the Manta device since launching the product in 2016 with over 100,000 patients treated worldwide. Our team is excited that this milestone allows us to now offer this innovative solution to patients in Canada and further address this important and previously unmet clinical need in the structural heart and endovascular space.

The device is available in 14 Fr and 18 Fr sizes to reduce hemostasis time following the use of 10-20 Fr devices or sheaths in endovascular catheterization procedures. In a prospective, multicenter, single-arm trial, Manta successfully demonstrated rapid and reliable biomechanical closure with rapid hemostasis with all primary and secondary endpoints achieved.

“In a selected patient population, this study has demonstrated that the Manta VCD can safely and effectively close large bore arteriotomies created by current-generation TAVR, PEVAR, and TEVAR devices,” said co-investigator David Wood. principal of the trial and director of the Center for Cardiovascular Innovation at UBC in Vancouver.

“Innovations such as the Manta device are helping to provide prompt care in busy operating rooms and cardiac catheterization labs,” said Chris Buller, Medical Director of Teleflex’s Interventional Business Unit. “Additionally, when used by operators fully trained in Manta device deployment, the device achieves industry-leading results in preventing complications attributable to large-bore vascular access site.”

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