US EditionCIRCA Scientific Announces FDA Clearance of PeriCross™ Epicardial Access Kit
- CIRCA Scientific obtained 510 clearance from the FDA for PeriCross Kit on April 24, 2025.
- Accessing the epicardial space remains technically demanding for many procedures.
- The PeriCross system employs a tine mechanism and needle for controlled subxiphoid access.
- Trial data from 21 patients showed 100% access success and a mean time of 3.5 minutes.
- The FDA clearance signifies a key milestone before the U.S. Market launch in coming months.
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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…
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