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SynCardia Freedom® Standby Kit Shipping Container

Details

Device typeVentricular prosthesis system, pneumatically-powered: An assembly of devices intended to function as an artificial replacement for failing heart ventricles (end-stage biventricular failure), typically temporarily prior to heart transplantation. It consists of two implanted pneumatically-powered pumping units, with built-in mechanical heart valves, which replace the excised natural heart ventricles and are connected to the heart atria, aorta, and pulmonary arteries; the prosthesis is driven by an external pneumatic pump connected via percutaneous pneumatic drive-lines entering the patient's chest.

FDA categoryArtificial Heart

Device ID00858000003015

AvailabilityPrescription

Single useYes

MRI safetyMR Unsafe

Contact

No contact is listed for this device.

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