CIRCA Scientific Reports the US FDA’s 510(k) Clearance of PeriCross Epicardial Access Kit for Controlled Pericardial Space Access
Shots:
- The US FDA has granted 510(k) clearance to PeriCross for controlled & efficient access to pericardial space through subxiphoid approach; US launch expected in coming mos., with select global expansion planned for 2026
- Preliminary EASY-R trial data (enrolment completed) in 21 pts showed 100% access success, with mean access time of 3.5 ± 2.2min, where 8/21 achieved access in ≤2min. Low fluoroscopy burden (2.1 ± 1.1min), & minimal contrast use (0.7 ± 0.2mL per case) were also observed; full data to be presented at HRS 2025
- PeriCross utilizes tine-based retraction mechanism with a 21G micro-puncture needle, allowing controlled separation of the pericardium & myocardium prior to needle advancement
Ref: PRNewswire | Image: CIRCA Scientific
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
