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Teleflex Expands Interventional Cardiology Portfolio With FDA 510(k) Clearance of the Ringer Perfusion Balloon Catheter
This milestone highlights Teleflex’s commitment to providing interventionalists with new tools specifically engineered to address unmet clinical needs.
This milestone highlights Teleflex’s commitment to providing interventionalists with new tools specifically engineered to address unmet clinical needs.
Teleflex Incorporated News
WAYNE, Pa.— Teleflex Incorporated, a global provider of medical technologies, 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
References:
- Data on file at Teleflex. Applicable to the US Market.
- Prolonged Balloon inflation is defined as balloon inflation equal to or greater than one minute. Data on file at Teleflex.
- 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.
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