Teleflex has announced US Food and Drug Administration (FDA) 510(k) clearance of the Ringer perfusion balloon catheter (PBC), describing it as the only commercially available percutaneous transluminal coronary angioplasty (PTCA) perfusion balloon.
The Ringer PBC is a rapid-exchange 0.014” compatible catheter with a helical balloon at its working end. 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 said in a press release.
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 ischaemia,” said Kathleen Kearney (University of Washington, Seattle, USA), principal investigator of the Ringer PTCA clinical study. “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. “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.”
