CIRCA Scientific Announces FDA Clearance of PeriCross™ Epicardial Access Kit

• CIRCA Scientific receives FDA 510(k) clearance for the PeriCross™ Epicardial Access Kit, a novel tine-based system designed to support controlled and efficient subxiphoid access to the pericardial space.
• Preliminary data from the EASY-R trial (n=21) demonstrated 100% access success, with a mean access time of 3.5 minutes, low fluoroscopy time, and minimal contrast usage. Results are being presented at HRS 2025.

ENGLEWOOD, Colo., April 24, 2025 /PRNewswire/ -- CIRCA Scientific is pleased to announce that the U.S. 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. 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 Dr. Petr Neuzil, Director of the Cardiac Arrhythmia Service at Na Homolce Hospital in Prague. "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 (Epicardial Access StudY with Rook) clinical trial demonstrate encouraging procedural outcomes¹:

• 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 2 minutes or less
• Low fluoroscopy burden, averaging 2.1 ± 1.1 minutes
• Minimal contrast use, with 0.7 ± 0.2 mL required per case

Dr. Vivek Reddy, The Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital in New York City, NY, commented, "PeriCross simplifies a complex step and fits naturally into existing workflows. It's intuitive, efficient, and reduces the variability that often comes with epicardial access."

Preliminary data from the study will be presented at the upcoming Heart Rhythm Society (HRS) 2025 Annual Meeting, taking place April 24–27 in San Diego, CA. Enrollment 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 & CEO of CIRCA Scientific. "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 U.S. market in the coming months, with further expansion to select international markets expected in 2026.

About CIRCA Scientific

CIRCA Scientific is dedicated to empowering physicians with innovative technologies that offer unprecedented access and control for complex medical interventions. Guided by a CardioCentric™ approach, we are committed to enhancing procedural success and advancing patient care. For more information on CIRCA Scientific and its portfolio of cardiac solutions, visit www.circascientific.com.

© CIRCA Scientific, Inc., 2025. All rights reserved. PeriCross, CardioCentric, CIRCA Scientific, and the CIRCA Scientific logo are trademarks of CIRCA Scientific, Inc. Patents: www.circascientific.com/patents. CAUTION: Federal law restricts this device to sale by or on the order of a physician. Please consult the Instructions for Use for indications, contraindications, warnings, and precautions.

1- Neuzil P, Petru J, Funasako M, Hala P, Skoda J, Weiss P, Reddy VK. A First-in-Human Clinical Experience with a Novel Tine-Based Pericardial Retraction and Needle Technology for Facile Epicardial Access. Poster presented at: Heart Rhythm Society Annual Scientific Sessions; April 24–27, 2025; San Diego, CA.

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SOURCE CIRCA Scientific, Inc.