The clearance expands Wayne, Pennsylvania–based Teleflex’s interventional cardiology portfolio. It enables the company to offer what it says is the only commercially available perfusion balloon — a balloon with a perfusion lumen that allows blood to flow through it while inflated — for use in PTCA procedures.
The Ringer perfusion balloon catheter — a rapid-exchange 0.014-in. compatible catheter — has a unique helical balloon at its working end. When inflated, this balloon is like a hollow cylinder with a large central perfusion lumen.
With blood able to flow continuously during a PTCA, doctors can opt for more prolonged inflations to achieve desired results, according to Teleflex. The perfusion lumen also could encourage innovation in PTCA procedures because it provides a passage for the delivery of secondary devices.
“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,” said Dr. Kathleen Kearney, principal investigator of the Ringer PTCA clinical study and an 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.”
Teleflex plans for a limited market release phase for the Ringer perfusion balloon catheter next 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 Dr. 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.”
