Teleflex reports efficacy of Ringer PBC in coronary procedures

Teleflex (TFX) announced that the preliminary results from its Ringer PBC IDE study were reported in a featured presentation at the CTO Plus Conference in New York. Ringer PBC is a rapid-exchange percutaneous transluminal coronary angioplasty catheter with a unique helical balloon, allowing for continuous coronary blood flow during prolonged inflations. The Ringer PBC study is a limited study in the U.S. investigating the Ringer PBC for the management of emergent coronary perforations that develop during percutaneous coronary intervention, or PCI, procedures. Of 30 participants enrolled, the primary efficacy endpoint was observed in 22 participants, 73.3%, with successful Ringer PBC delivery in 26 participants, or 86.7%. Among those participants with successful delivery, control of extravasation with perfusion was achieved in 22 participants. Ringer PBC 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. Data from the study is intended to support a premarket application recently submitted to FDA.