Teleflex (NYSE: TFX) announced today that it completed patient enrollment in its prospective multicenter Ringer PTCA study.
Ringer PTCA is one of two clinical studies evaluating Teleflex’s novel Ringer perfusion balloon catheter. The trial enrolled patients across seven leading complex percutaneous coronary intervention (PCI) centers in the U.S. and Canada. Dr. Kathleen Kearney of the University of Washington leads the trial.
Kearney said in a news release that Ringer’s availability “is much anticipated by the interventional cardiology community.” She added that completed enrollment in the trial marks “a big step” toward that milestone.
Wayne, Pennsylvania-based Teleflex said the study employed Ringer in selected coronary intervention patients who could benefit from continued perfusion during coronary balloon inflations.
Parallel to Ringer PTCA, Teleflex has a 30-patient prospective study underway evaluating the safety and utility of Ringer. That study looks at Ringer for emergently managing coronary perforations complicating PCI procedures. Coronary perforations, though infrequent, can represent life-threatening events demanding rapid treatment, Teleflex said. No commercially available devices currently exist for temporarily controlling bleeding from coronary perforations pending definitive treatment or to seal perforations without leaving behind a permanent coronary implant, according to the company.
“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.
