WAYNE, PA — Teleflex Incorporated (NYSE: TFX) has shared promising preliminary results from its Ringer™ PBC IDE study, featured in a presentation at the CTO Plus Conference in New York. The presentation, delivered by the study’s principal investigator, Dr. David E. Kandzari of Piedmont Heart Institute, highlighted the potential of the Ringer™ PBC device in managing coronary perforations during percutaneous coronary intervention (PCI) procedures.
Ringer™ PBC, a rapid-exchange percutaneous transluminal coronary angioplasty (PTCA) catheter, features a unique helical balloon that allows continuous coronary blood flow during prolonged inflations. The study, a prospective, multi-center, single-arm clinical trial, enrolled 30 participants across four U.S. sites. Its primary aim was to evaluate the device’s ability to control coronary perforations by achieving successful delivery and inflation to manage extravasation, while preserving antegrade coronary flow.
Results showed the Ringer™ PBC achieved the primary efficacy endpoint in 73.3% of participants, with the device successfully delivered in 86.7% of cases. Among these, 84.6% experienced controlled extravasation with continued perfusion. While most cases had favorable outcomes, one participant required emergency surgery, and three participants died despite achieving perforation control, underscoring the complexity of such high-risk scenarios.
“I believe these preliminary study results are important,” stated Dr. Kandzari. “Treatment options for patients with coronary artery perforations during PCI cases have been limited to date, and this trial points the way to developing dedicated devices.”
The Ringer™ PBC has also earned the FDA’s Breakthrough Device Designation, a regulatory pathway that expedites the development and review of medical devices targeting life-threatening or debilitating conditions. This designation underscores the device’s potential to enhance outcomes for patients facing critical cardiac interventions.
“Teleflex is committed to generating the clinical evidence to help physicians make confident decisions when selecting the right products for their patients’ needs,” added Christopher Buller, MD, Teleflex Medical Director.
While Ringer™ PBC is investigational and not yet commercially available, the study’s results will be instrumental in supporting the company’s premarket application recently submitted to the FDA. The findings affirm Teleflex’s dedication to advancing medical innovation and providing critical solutions for challenging cardiovascular conditions.
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