The approval will enable the firm to increase the availability of the MANTA device globally, and it gives Canadian clinicians access to another innovative Teleflex device
US-based medical technology company Teleflex has received approval from Health Canada for its MANTA vascular closure device.
According to the firm, the device is the first commercially available biomechanical vascular closure device intended for large bore femoral arterial access site closure.
The approval will enable the firm to increase the availability of the MANTA device globally, and it gives Canadian clinicians access to another innovative Teleflex device.
The MANTA Device, which is available in 14 Fr. and 18 Fr., is used to close femoral artery access sites while shortening time to hemostasis after using 10-20F devices or sheaths (12-25F OD) in endovascular catheterisation procedures.
Teleflex Interventional Business Unit general manager and president Scott Holstine said: “Our team has been working diligently to obtain this approval and were confident that Health Canada would recognize the benefits of the MANTA Device.
“We have had great success with the MANTA Device since the launch of the product in 2016 with over 100,000 patients treated worldwide.
“Our team is thrilled that this milestone allows us to now offer this innovative solution to patients in Canada and further fulfill this significant and previously unmet clinical need in the structural heart and endovascular space.”
The SAFE MANTA IDE Clinical Trial, a prospective multi-center, single-arm trial, demonstrated that the MANTA device has the ability to deliver rapid reliable biomechanical closure with rapid hemostasis.
Teleflex Interventional Business Unit medical director Chris Buller said: “Innovations like the MANTA Device contribute to time-efficient care in busy operating rooms and cardiac catheterization laboratories.
“Moreover, when used by operators fully trained in MANTA Device deployment, the device achieves state-of-the-art results with respect to prevention of complications attributable to the large-bore vascular access site.”
Recently, the company announced the commercial availability of its UroLift 2 System and UroLift ATC System in the US.