WAYNE, PA — Teleflex Incorporated (NYSE: TFX) announced the completion this week of patient enrollment in the prospective multicenter Ringer™ PTCA study. Ringer™ PTCA is one of two clinical studies evaluating the performance of the novel Ringer™ Perfusion Balloon Catheter. The Ringer™ PTCA study enrolled patients at seven leading complex PCI centers in the US and Canada. Led by Principal Investigator Kathleen Kearney M.D., University of Washington, the study employed the RingerTM Device in selected coronary intervention patients who could benefit from continued perfusion during coronary balloon inflations.
“Completing enrollment is a significant milestone in the clinical validation and regulatory pathway to release the Ringer™ Perfusion Balloon Catheter to treat patients,” said Teleflex Medical Director, Dr. Christopher Buller.
Running in parallel to the Ringer™ PTCA study is a 30-patient prospective study evaluating the safety and utility of Ringer™ for emergently managing coronary perforations complicating PCI procedures. Coronary perforations, though infrequent, can be life-threatening events that demand rapid treatment. 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.
“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,” said Kathleen Kearney M.D., University of Washington.