• The Ringer™ PBC study is a limited prospective, multi-center, single-arm IDE study, undertaken at four sites in the United States investigating the Ringer™ PBC for the management of emergent coronary perforations that develop during percutaneous coronary intervention (PCI) procedures. The study enrolled 30 participants, and analysis was performed based upon 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).
• Of 30 participants enrolled, the primary efficacy endpoint was observed in 22 participants (73.3%), with successful Ringer™ PBC delivery in 26 participants (86.7%). Among those participants with successful delivery, control of extravasation with perfusion was achieved in 22 participants (84.6%). Twelve participants were treated with a covered stent following perforation management with the Ringer™ PBC. One participant required emergency surgery for complications of pericardiocentesis, and three participants died despite control of extravasation from the index perforation.

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