#United States #FDA Clearance #Englewood #CIRCA Scientific #PeriCross™

CIRCA Scientific's FDA Clearance of PeriCross™ Access Kit

CIRCA Scientific recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative PeriCross™ Epicardial Access Kit, formerly known as the Rook®. This cutting-edge medical device aims to facilitate controlled and efficient access to the pericardial space through a subxiphoid approach, marking a significant advancement in cardiac procedures.

Epicardial access has long been recognized as a challenging aspect of various electrophysiology and structural heart procedures. The dual functionalities of the PeriCross system incorporate a unique tine-based retraction mechanism along with a 21-gauge micro-puncture needle. This innovative design allows practitioners to create a spatial separation between the pericardium and myocardium, enhancing the control and consistency of the access process.

According to Dr. Petr Neuzil, the Director of the Cardiac Arrhythmia Service at Na Homolce Hospital in Prague, the PeriCross system simplifies a difficult phase in epicardial procedures. He shared, "Our early clinical experience has shown that the device performs reliably and efficiently across a range of patient anatomies."

Preliminary results from the EASY-R Trial (Epicardial Access Study with Rook), involving 21 patients, demonstrate promising outcomes. The trial reported a 100% success rate in achieving access to the pericardial space, with an average access time of just 3.5 minutes. Impressively, 38.1% of cases achieved access in less than 2 minutes, underscoring the device's effectiveness. The fluoroscopy times were notably low, averaging only 2.1 minutes, and the contrast use was minimal at just 0.7 mL per case.

Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at The Mount Sinai Fuster Heart Hospital, expressed his enthusiasm about the device, stating, "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."

The forthcoming Heart Rhythm Society (HRS) 2025 Annual Meeting, scheduled for April 24-27 in San Diego, CA, will feature comprehensive data from the EASY-R trial. This research showcases the PeriCross device in action and will contribute to ongoing discussions about innovations in cardiac care.

Lee Geist, President and CEO of CIRCA Scientific, remarked, "The FDA clearance of PeriCross represents a significant milestone in our strategy to provide physicians with differentiated access tools for complex cardiac procedures. It is a meaningful addition to our portfolio and reflects our ongoing commitment to a CardioCentric™ approach to procedural innovation."

CIRCA Scientific plans to launch PeriCross in the U.S. market in the upcoming months, with further international expansion projected for 2026.

About CIRCA Scientific

CIRCA Scientific is dedicated to empowering healthcare professionals with innovative technologies that offer unparalleled access and control for complex medical interventions. Through their CardioCentric™ approach, the company aims to enhance procedural success and improve patient care. To learn more about CIRCA Scientific and its diverse portfolio of cardiac solutions, visit www.circascientific.com.

Caution: Federal law restricts this device’s sale to or on the order of a physician. Consult the Instructions for Use for indications, contraindications, warnings, and precautions.