WAYNE, PA — Teleflex Incorporated (NYSE: TFX) this week announced that it received Health Canada approval for the MANTA® Vascular Closure Device – the first commercially available biomechanical vascular closure device designed specifically for large bore femoral arterial access site closure.1 This approval marks an important milestone in the regulatory plan to expand the availability of the MANTA® Device globally and provides access to another uniquely designed device from Teleflex to Canadian clinicians.
“Our team has been working 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 the Teleflex Interventional Business Unit. “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.”
Available in 14 Fr. and 18 Fr., the MANTA® 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 North American (Canada and US) 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.2
“In a selected population of patients, this study demonstrated that the MANTA VCD can safely and effectively close large bore arteriotomies created by current generation TAVR, PEVAR, and TEVAR devices,” concluded Dr. David A. Wood*, Co-Principal Investigator and Director of the UBC Centre for Cardiovascular Innovation in Vancouver, British Columbia.
“Innovations like the MANTA® Device contribute to time-efficient care in busy operating rooms and cardiac catheterization laboratories,” said Chris Buller, MD, Medical Director of the Teleflex Interventional Business Unit. “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.”
With the MANTA® Device, clinicians and hospitals in Canada can now also achieve:
- Successful large bore closure with a device that does not require pre-closure, saving valuable time during the most delicate interventional procedures.
- Proven and reproducible results using only one device with straightforward auditory “click” cues that make it dependably simple to deploy and easy to use.2a,b
For more information, visit teleflex.com.
- Data on file at Teleflex.
- The SAFE MANTA IDE Clinical Trial.
- Percutaneous vascular closure obtained with the MANTA® Device without the use of unplanned endovascular or surgical intervention.
- A single MANTA® Vascular Closure Device was deployed in 99.6% of subjects in IDE trial.
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