Teleflex Announces Health Canada Approval of MANTA® Vascular Closure Device

Rhea-AI Summary

Teleflex (NYSE: TFX) has received Health Canada approval for the MANTA^® Vascular Closure Device, marking a significant regulatory milestone. This device is designed for large bore femoral arterial access site closure and enhances the availability of innovative solutions for Canadian clinicians. Since its launch in 2016, over 100,000 patients have been treated with the MANTA^® Device worldwide. The SAFE MANTA IDE Clinical Trial demonstrated the device's effectiveness in achieving rapid hemostasis without the need for pre-closure, enabling quicker and safer procedures.

Positive

• Health Canada approved MANTA^® Device for large bore femoral arterial access site closure.
• Over 100,000 patients treated globally since the product's launch in 2016.
• The device allows for faster hemostasis, improving procedural efficiency.

Negative

• None.

WAYNE, Pa., May 18, 2022 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today has 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

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular access, interventional cardiology and radiology, anesthesia, emergency medicine, surgical, urology and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.

Teleflex is the home of Arrow^®, Deknatel^®, LMA^®, Pilling^®, QuikClot^®, Rusch^®, UroLift^®, and Weck^® – trusted brands united by a common sense of purpose.

Forward-Looking Statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Any forward-looking statements contained herein are based on our management's current beliefs and expectations, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or company actions to differ materially from what is expressed or implied by these statements. These risks and uncertainties are identified and described in more detail in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

Teleflex, the Teleflex logo, Arrow, Deknatel, LMA, MANTA, Pilling, QuikClot, Rusch, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.

© 2022 Teleflex Incorporated. All rights reserved. MC-008025 Rev 0

*Dr. Wood is a paid consultant of Teleflex Incorporated.

References:

1. Data on file at Teleflex.
2. The SAFE MANTA IDE Clinical Trial.
   1. Percutaneous vascular closure obtained with the MANTA^® Device without the use of unplanned endovascular or surgical intervention.
   2. A single MANTA^® Vascular Closure Device was deployed in 99.6% of subjects in IDE trial.

Contacts:

For Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development

John Hsu, CFA
Vice President, Investor Relations

investor.relations@teleflex.com
610-948-2836

Source:

Teleflex Incorporated

FAQ

What is the significance of the MANTA® Device approval by Health Canada for TFX?

The approval allows Teleflex to expand the availability of the MANTA® Device in Canada, addressing a significant clinical need.

How many patients have used the MANTA® Device since its launch?

Since its launch in 2016, the MANTA® Device has been used to treat over 100,000 patients worldwide.

What are the benefits of the MANTA® Device in medical procedures?

The MANTA® Device achieves rapid hemostasis, reducing procedure time and potentially lowering complication risks.

Which trial validated the effectiveness of the MANTA® Device?

The SAFE MANTA IDE Clinical Trial validated the device's effectiveness in achieving quick and reliable closure.

What does the approval of the MANTA® Device mean for Canadian clinicians?

Canadian clinicians now have access to an innovative solution for large bore femoral access site closure, enhancing patient care.