WAYNE, PA — Teleflex Incorporated (NYSE: TFX) announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the Ringer™ Perfusion Balloon Catheter (PBC) this week. It is the only commercially available Percutaneous Transluminal Coronary Angioplasty (PTCA) perfusion balloon.
The Ringer™ PBC features a rapid-exchange 0.014” compatible catheter with a unique helical balloon at its working end. When inflated, the balloon forms a hollow cylinder with a large central perfusion lumen, allowing continuous coronary blood flow during prolonged inflations. This device is intended for balloon dilatation of coronary artery or coronary bypass graft stenoses, enhancing myocardial perfusion by maintaining distal blood flow during balloon inflation. Additionally, the lumen can serve as a passage for secondary devices, opening new avenues for procedural innovation.
“The Ringer PTCA Clinical Study demonstrated that inflation of the Ringer™ PBC for 60 seconds or more was well tolerated in most patients who are vulnerable to procedural ischemia,” 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 limited market release of the Ringer™ Perfusion Balloon Catheter is set for August 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.”
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