August 1, 2024- Teleflex Incorporated 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.
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. 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.