Teleflex’s Ringer Perfusion Balloon Catheter Receives FDA Clearance

July 31, 2024—Teleflex Incorporated announced FDA 510(k) clearance of the Ringer perfusion balloon catheter (PBC) for percutaneous transluminal coronary angioplasty (PTCA). The company advised that the Ringer PBC will enter a limited market release phase in August 2024.

According to Teleflex, the Ringer PBC is a rapid-exchange 0.014-inch–compatible catheter with a helical balloon at its working end. The company noted that, when inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen. These characteristics allow for continuous coronary blood flow during prolonged inflations.

Teleflex stated that 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.

Kathleen Kearney, MD, an interventional cardiologist at the University of Washington in Seattle, Washington, is principal investigator of the Ringer PTCA clinical study.

“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,” commented Dr. Kearney in the Teleflex press release. “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.”