Circa Scientific has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the PeriCross epicardial access kit (formerly Rook), a purpose-built solution designed to enable controlled and efficient access to the pericardial space via a subxiphoid approach.
Epicardial access remains a “technically demanding” step in many electrophysiology and structural heart procedures, as per a press release from the company.
The PeriCross system features a unique tine-based retraction mechanism integrated with a 21-gauge micro-puncture needle, allowing physicians to create separation between the pericardium and myocardium prior to needle advancement—a design intended to improve control, support procedural consistency, and streamline workflow.
“The PeriCross system addresses one of the most challenging aspects of epicardial procedures with an elegant and intuitive design,” said Petr Neužil (Na Homolce Hospital, Prague, Czechia). “Our early clinical experience has shown that the device performs reliably and efficiently across a range of patient anatomies.”
Preliminary results from the first 21 patients enrolled in the EASY-R clinical trial demonstrate encouraging procedural outcomes, including:
- A 100% success rate in achieving pericardial access
- Mean access time of 3.5±2.2 minutes (range, 1–8 minutes); eight of the 21 cases (38.1%) achieved access in two minutes or less
- Low fluoroscopy burden, averaging 2.1±1.1 minutes
- Minimal contrast use, with 0.7±0.2mL required per case
“PeriCross simplifies a complex step and fits naturally into existing workflows,” stated Vivek Reddy (Mount Sinai Fuster Heart Hospital, New York City, USA). “It’s intuitive, efficient, and reduces the variability that often comes with epicardial access.”
Preliminary data from the EASY-R study were presented at the 2025 Heart Rhythm Society (HRS) annual meeting (24–27 April, San Diego, USA). According to Circa, enrolment in the trial is now complete and full clinical results will be submitted for peer-reviewed publication.
“The FDA clearance of PeriCross represents a significant milestone in our strategy to provide physicians with differentiated access tools for complex cardiac procedures,” said Lee Geist, president and chief executive officer (CEO) of Circa. “It’s a meaningful addition to our portfolio and reflects our ongoing commitment to a CardioCentric approach to procedural innovation.”
PeriCross will launch within the US market in the coming months, with further expansion to select international markets expected in 2026.
