Teleflex Announces Health Canada Approval of MANTA®

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WAYNE, Pa., May 18, 2022 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), one of the world’s leading medical technology providers, today announced that it has received Health Canada approval for MANTA® Vascular Closure Device – the first commercially available biomechanical vascular closure device designed specifically for closure of the large bore femoral arterial access site.1 This approval marks an important step in the regulatory plan to expand the availability of MANTA® Device globally and provides access to another uniquely designed Teleflex device to Canadian clinicians.

“Our team worked diligently to obtain this approval and were confident that Health Canada would recognize the benefits of 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 product launch 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.

Available in 14 Charr. and 18 Fr., the MANTA® The device is indicated for closure of femoral arterial access sites while reducing hemostasis time following the use of 10-20F (12-25F OD) devices or sheaths in endovascular catheterization procedures. The SAFE MANTA IDE clinical trial, the largest North American (Canada and United States) prospective, multicenter, single-arm trial of a specially designed large-bore femoral access site closure, has demonstrated that the MANTA® The device successfully achieves rapid and reliable biomechanical closure with rapid hemostasis, with all primary and secondary endpoints met.2

“In a selected patient population, 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 Center for Cardiovascular Innovation in Vancouver, British Columbia.

“Innovations like the MANTA® The device contributes to prompt care in busy operating rooms and cardiac catheterization labs,” said Chris Buller, MD, Medical Director of Teleflex’s Interventional Business Unit. “Furthermore, when used by fully MANTA trained operators® Deployment of the device, the device achieves breakthrough results in preventing complications attributable to large caliber vascular access site. »

With the MANTA® Devices, clinicians and hospitals in Canada can now also perform:

  • Successful high-calibre closure with a device that does not require pre-closure, saving valuable time during the most delicate interventional procedures.
  • Proven, repeatable results using a single device with simple auditory “click” cues that make it reliable and simple to deploy and easy to use.2a B

About Teleflex Incorporated

Teleflex is a global provider of medical technologies designed to improve people’s health and quality of life. We apply goal-driven innovation – a relentless pursuit of identifying unmet clinical needs – for the benefit of patients and healthcare providers. Our portfolio is diverse, with solutions in Vascular Access, Interventional Cardiology and Radiology, Anesthesia, Emergency Medicine, Surgery, Urology and Respiratory Care . Teleflex employees around the world are united in the understanding that what we do every day makes a difference. For more information, visit teleflex.com.

Teleflex is the home of Arrow®Deknatel®AML®pilling®QuikClot®Rusch®UroLift®and Weck® – trusted brands united by a common goal.

Forward-looking statements

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. All forward-looking statements contained herein are based on the current beliefs and expectations of our management, but are subject to a number of risks, uncertainties and changes in circumstances, which may cause actual results or of the company materially different 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 subsidiaries, in the United States and/or other countries .

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

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

References:

  1. Data on file with Teleflex.
  2. The SAFE MANTA IDE clinical trial.
    1. Percutaneous vascular closure obtained with MANTA® Device without the need for unplanned endovascular or surgical intervention.
    2. A single MANTA® The vascular closure device was deployed in 99.6% of subjects in the IDE trial.

contacts:

For Teleflex Incorporated:
Laurent Keusch
Vice President, Investor Relations and Strategic Development

John Hsu, CFA
Vice President, Investor Relations

[email protected]
610-948-2836

Source:

Incorporated Teleflex


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