Teleflex Ringer Perfusion Balloon Catheter’s PTCA Study Completes Enrollment

July 19, 2023—Teleflex Incorporated announced the completion of patient enrollment in the prospective multicenter Ringer percutaneous transluminal coronary angioplasty (PTCA) study, which is one of two clinical studies evaluating the performance of the company’s Ringer perfusion balloon catheter.

According to the company, the Ringer PTCA study enrolled patients at seven leading complex percutaneous coronary intervention (PCI) centers in the United States and Canada. Investigators employed the Ringer device in selected PCI patients who could benefit from continued perfusion during coronary balloon inflations. Ringer is an investigational device and is limited by federal (or United States) law to investigational use, noted Teleflex.

The Ringer PTCA study is led by Principal Investigator Kathleen Kearney, MD, of the University of Washington in Seattle, Washington.

“Availability of Ringer is much anticipated by the interventional cardiology community, and completion of enrollment in Ringer PTCA puts us a big step closer to that goal,” commented Dr. Kearney in the Teleflex press release.

Teleflex advised that a 30-patient prospective study evaluating the safety and utility of Ringer for emergently managing coronary perforations complicating PCI procedures is running in parallel to the Ringer PTCA study. The company stated that coronary perforations, though infrequent, can be life-threatening events that demand rapid treatment and, currently, there are no commercially available devices designed to temporarily control bleeding from coronary perforations pending definitive treatment or to seal perforations without leaving behind a permanent coronary implant.