FDA OKs Teleflex’s Ringer Perfusion Balloon Catheter

Teleflex has gained U.S. Food and Drug Administration (FDA) 510(k) for its Ringer perfusion balloon catheter (PBC). According to the company, it’s 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 the working end. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen. Teleflex said these characteristics allow continuous coronary blood flow during prolonged inflations.
 
The PBC is indicated for balloon dilatation of the coronary artery of coronary bypass graft stenoses, where distal blood perfusion during inflation is desired to improve myocardial perfusion. During PTCA the lumen is a passage for delivery of secondary devices.
 
Teleflex said the Ringer PBC will begin limited market release this month.
 
“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.”
 
In May, the company showcased findings from trials using the Prostatic Urethral Lift (PUL) with the UroLift System for benign prostatic hyperplasia (BPH).