Teleflex Expands Interventional Cardiology Portfolio with FDA 510(k) Clearance of the Ringer™ Perfusion Balloon Catheter

Rhea-AI Summary

Teleflex Incorporated (NYSE: TFX) has received FDA 510(k) clearance for its Ringer™ Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon. This innovative device features a unique helical balloon that allows for continuous coronary blood flow during prolonged inflations. The Ringer™ PBC is indicated for balloon dilatation of coronary artery or bypass graft stenoses where distal blood perfusion is desired during inflation.

The Ringer PTCA Clinical Study showed that inflation of the Ringer™ PBC for 60 seconds or more was well-tolerated in most patients vulnerable to procedural ischemia. Teleflex plans a market release in August 2024, marking a significant advancement in interventional cardiology and demonstrating the company's commitment to addressing unmet clinical needs.

Positive

• FDA 510(k) clearance received for Ringer™ Perfusion Balloon Catheter
• Unique helical balloon design allows continuous coronary blood flow during prolonged inflations
• Clinical study demonstrated good tolerance in patients vulnerable to procedural ischemia
• market release planned for August 2024

Negative

• None.

This milestone highlights Teleflex’s commitment to providing interventionalists with new tools specifically engineered to address unmet clinical needs.

WAYNE, Pa., July 31, 2024 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Ringer™ Perfusion Balloon Catheter (PBC), the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon.¹

The Ringer™ PBC is a rapid-exchange 0.014” compatible catheter with a unique helical balloon at its working end. When inflated, this balloon approximates a hollow cylinder with a large central perfusion lumen. These characteristics allow for continuous coronary blood flow during prolonged inflations.² The Ringer™ PBC is indicated for balloon dilatation of coronary artery or coronary bypass graft stenoses where the physician desires distal blood perfusion during balloon inflation for the purpose of improving myocardial perfusion. In addition, during PTCA the lumen serves as a passage for delivery of secondary devices creating new opportunities for procedural innovation.

"The Ringer PTCA Clinical Study demonstrated that inflation of the Ringer™ PBC for 60 seconds or more was well tolerated in the majority of patients who are vulnerable to procedural ischemia,³" said Kathleen Kearney, MD, Principal Investigator of the Ringer PTCA Clinical Study and Interventional Cardiologist at the University of Washington. "We have been eagerly awaiting the arrival of the Ringer™ PBC because of the potential its unique properties have to contribute to patient safety and evolve our practice in the most complex PTCA cases."

The Ringer™ Perfusion Balloon Catheter will enter a limited market release phase in August of 2024.

"The FDA 510(k) clearance of the Ringer™ Perfusion Balloon Catheter signifies a crucial achievement in Teleflex's commitment to advancing medical innovation and improving patient outcomes,” said Teleflex Medical Director, Christopher Buller, MD. “We listen carefully to the challenges that interventionalists face daily and are proud, once again, to introduce a solution for unmet needs with this revolutionary PTCA perfusion balloon.”

About Teleflex Incorporated

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose driven innovation, and world-class products can shape the future direction of healthcare.

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

At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com

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.

References:

1. Data on file at Teleflex. Applicable to the US Market.
2. Prolonged Balloon inflation is defined as balloon inflation equal to or greater than one minute. Data on file at Teleflex.
   
3. Data of File at Teleflex. Ringer Perfusion Balloon Catheter Percutaneous Intervention (PTCA) Clinical Study. Symptoms of ischemia include chest pain, ECG changes, and hemodynamic changes.
   

CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, Quik-Clot, Ringer, UroLift, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S. and/or other countries. Refer to the Instructions for Use for a complete listing of the indications, contraindications, warnings, and precautions. Information in this document is not a substitute for the product Instructions for Use. Not all products may be available in all countries. Please contact your local representative. 

© 2024 Teleflex Incorporated. All rights reserved. MC-009863 Rev 0.

Contacts:

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

investor.relations@teleflex.com
610.948.2836

FAQ

What is the Ringer™ Perfusion Balloon Catheter (PBC) by Teleflex (TFX)?

The Ringer™ PBC is a unique PTCA perfusion balloon catheter with a helical balloon design that allows continuous coronary blood flow during prolonged inflations. It received FDA 510(k) clearance and is indicated for balloon dilatation of coronary artery or bypass graft stenoses.

When will Teleflex (TFX) release the Ringer™ Perfusion Balloon Catheter?

Teleflex plans to begin a market release of the Ringer™ Perfusion Balloon Catheter in August 2024.

What were the results of the Ringer PTCA Clinical Study for Teleflex's (TFX) new catheter?

The Ringer PTCA Clinical Study demonstrated that inflation of the Ringer™ PBC for 60 seconds or more was well-tolerated in the majority of patients who are vulnerable to procedural ischemia.

How does the Ringer™ Perfusion Balloon Catheter by Teleflex (TFX) differ from other PTCA balloons?

The Ringer™ PBC is the only commercially available PTCA perfusion balloon. Its unique helical balloon design creates a large central perfusion lumen, allowing for continuous coronary blood flow during prolonged inflations and passage for delivery of secondary devices.