FDA Clears CIRCA Scientific's PeriCross™ Epicardial Access Kit with 100% Success Rate in Clinical Trial
核心洞察
CIRCA Scientific (搜索) has received FDA 510(k) clearance for the PeriCross (搜索)™ Epicardial Access Kit, featuring a novel tine-based retraction mechanism designed to improve pericardial access during cardiac procedures.
Preliminary data from the EASY-R (搜索) trial demonstrated a 100% success rate in achieving pericardial access, with a mean access time of just 3.5 minutes and minimal fluoroscopy and contrast requirements.
The innovative device addresses a technically challenging aspect of electrophysiology and structural heart procedures, with full clinical results to be published following presentation at HRS 2025.
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to CIRCA Scientific (搜索) for its PeriCross (搜索)™ Epicardial Access Kit, a purpose-built solution designed to enable controlled and efficient access to the pericardial space via a subxiphoid approach.
The PeriCross (搜索) system, formerly known as Rook®, features a unique tine-based retraction mechanism integrated with a 21-gauge micro-puncture needle. This innovative design allows physicians to create separation between the pericardium and myocardium prior to needle advancement—a critical step intended to improve control, support procedural consistency, and streamline workflow during complex cardiac procedures.
Promising Clinical Results
Preliminary data from the first 21 patients enrolled in the EASY-R (搜索) (Epicardial Access StudY with Rook) clinical trial have demonstrated remarkably positive outcomes. The device achieved a 100% success rate in establishing pericardial access, with a mean access time of just 3.5 ± 2.2 minutes. Notably, 38.1% of cases achieved access in 2 minutes or less.
Additional performance metrics were equally impressive:
- Low fluoroscopy burden, averaging only 2.1 ± 1.1 minutes
- Minimal contrast use, with just 0.7 ± 0.2 mL required per case
These results are particularly significant given that epicardial access remains one of the most technically demanding steps in many electrophysiology and structural heart procedures.
Expert Perspectives
Dr. Petr Neuzil, Director of the Cardiac Arrhythmia Service at Na Homolce Hospital (搜索) in Prague, who has experience with the device, noted: "The PeriCross (搜索) system addresses one of the most challenging aspects of epicardial procedures with an elegant and intuitive design. Our early clinical experience has shown that the device performs reliably and efficiently across a range of patient anatomies."
Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital (搜索) in New York City, added: "PeriCross (搜索) simplifies a complex step and fits naturally into existing workflows. It's intuitive, efficient, and reduces the variability that often comes with epicardial access."
Clinical Trial and Future Plans
Preliminary data from the EASY-R (搜索) study will be presented at the Heart Rhythm Society (搜索) (HRS) 2025 Annual Meeting, taking place April 24–27 in San Diego, California. Enrollment in the trial is now complete, and full clinical results will be submitted for peer-reviewed publication.
"The FDA clearance of PeriCross (搜索) represents a significant milestone in our strategy to provide physicians with differentiated access tools for complex cardiac procedures," said Lee Geist, President & CEO of CIRCA Scientific (搜索). "It's a meaningful addition to our portfolio and reflects our ongoing commitment to a CardioCentric™ approach to procedural innovation."
Market Availability
CIRCA Scientific (搜索) plans to launch PeriCross (搜索) within the U.S. market in the coming months, with expansion to select international markets expected in 2026. The device is designed to address a specific technical challenge in cardiac procedures while potentially reducing procedure time and improving consistency.
The company, based in Englewood, Colorado, focuses on developing innovative technologies that offer improved access and control for complex medical interventions, with a particular emphasis on cardiac procedures.