Teleflex’s Ringer PBC Studied for Management of Coronary Perforations

March 31, 2025—Teleflex Incorporated announced preliminary results from its Ringer perfusion balloon catheter (PBC) investigational device exemption (IDE) study. The limited prospective, multicenter, single-arm IDE study is being undertaken at four sites in the United States to investigate the Ringer PBC for the management of emergent coronary perforations that develop during percutaneous coronary intervention (PCI) procedures.

According to the company, the Ringer PBC is a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter that features a helical balloon. When inflated, the balloon approximates a hollow cylinder with a large central perfusion lumen, allowing for continuous coronary blood flow during prolonged inflations.

The Ringer PBC in this study is an investigational device and not available for sale. Data from the study is intended to support a premarket application recently submitted to FDA, advised Teleflex.

David E. Kandzari, MD, the study’s Principal Investigator, reported the findings during a featured presentation at the CTO Plus Conference held February 28 to March 1 in New York, New York. Dr. Kandari is Chief, Piedmont Heart Institute and Cardiovascular Services, Chief Scientific Officer and Director, Interventional Cardiology at Piedmont Heart Institute in Atlanta, Georgia.

As summarized in the Teleflex press release, the study enrolled 30 patients. The analysis was performed based on intention-to-treat. The primary efficacy endpoint required successful Ringer PBC delivery and inflation at the perforation site, control of extravasation (defined as residual Ellis grade 0 or 1), and preservation of antegrade coronary flow (thrombolysis in myocardial infarction—TIMI—grade 2 or 3).

The company reported that the primary efficacy endpoint was observed in 22 of the 30 enrolled patients (73.3%), with successful Ringer PBC delivery in 26 patients (86.7%).

Among those patients with successful delivery, control of extravasation with perfusion was achieved in 22 patients (84.6%). Twelve patients were treated with a covered stent after perforation management with the Ringer PBC. One patient required emergency surgery for complications of pericardiocentesis, and three patients died despite control of extravasation from the index perforation, stated Teleflex.

“I believe these preliminary study results are important,” commented Dr. Kandzari in the Teleflex press release. “Treatment options for patients with coronary artery perforations during PCI cases have been limited to date, and this trial points the way to developing dedicated devices.”

For the investigational use of the management of coronary perforations, Ringer PBC was granted the FDA’s Breakthrough Device designation.

In July 2024, Teleflex announced FDA 510(k) clearance of the Ringer PBC for PTCA procedures. It is currently 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.