Teleflex Completes Enrollment in Percutaneous Coronary Intervention Study
- Completion of patient enrollment in the Ringer™ PTCA study is a positive step in the clinical validation and regulatory pathway for the release of the Ringer™ Perfusion Balloon Catheter. The study, led by Principal Investigator Kathleen Kearney M.D., aims to validate the device's clinical efficacy and regulatory pathway for release.
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Enrollment Complete in Study Evaluating the Performance of the Ringer™ Perfusion Balloon Catheter in Patients Undergoing Percutaneous Coronary Interventions
WAYNE, Pa., July 19, 2023 (GLOBE NEWSWIRE) -- Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced the completion of patient enrollment in the prospective multicenter RingerTM PTCA study. RingerTM PTCA is one of two clinical studies evaluating the performance of the novel RingerTM Perfusion Balloon Catheter. The RingerTM PTCA study enrolled patients at seven leading complex PCI centers in the US and Canada. Led by Principal Investigator Kathleen Kearney M.D., University of Washington, the study employed the RingerTM Device in selected coronary intervention patients who could benefit from continued perfusion during coronary balloon inflations.
“Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to release the RingerTM Perfusion Balloon Catheter to treat patients,” said Teleflex Medical Director, Dr. Christopher Buller.
Running in parallel to the RingerTM PTCA study is a 30-patient prospective study evaluating the safety and utility of RingerTM for emergently managing coronary perforations complicating PCI procedures. Coronary perforations, though infrequent, can be life-threatening events that demand rapid treatment. Currently there are no commercially available devices designed to temporarily control bleeding from coronary perforations pending definitive treatment or to seal perforations without leaving behind a permanent coronary implant.
“Availability of RingerTM is much anticipated by the interventional cardiology community, and completion of enrollment in RingerTM PTCA puts us a big step closer to that goal,” said Kathleen Kearney M.D., University of Washington.
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.
*Dr. Kearney is a paid consultant of Teleflex Incorporated.
CAUTION: RingerTM is an investigational device and is limited by federal (or United States) law to investigational use.
CAUTION: Federal (USA) law restricts these devices for sale or use by or on the order of a physician.
Teleflex, the Teleflex logo, Arrow, Deknatel, GuideLiner, LMA, Pilling, QuikClot, Ringer, Rusch, 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.
© 2023 Teleflex Incorporated. All rights reserved. MC-009018.
Contacts:
For Teleflex Incorporated:
Lawrence Keusch
Vice President, Investor Relations and Strategy Development
investor.relations@teleflex.com
610.948.2836
FAQ
What is the purpose of the Ringer™ PTCA study completed by Teleflex Incorporated (NYSE: TFX)?
Who led the Ringer™ PTCA study?
What is the significance of completing patient enrollment in the Ringer™ PTCA study?
What is the parallel study being conducted alongside the Ringer™ PTCA study?
