SynCardia Systems LLC is pleased to announce that the US Food and Drug Administration (FDA) has approved significant software upgrades to the Freedom Portable Driver.
This upgrade will further improve the accuracy of the cardiac output and fill volume measurements to 5% at normotensive conditions. on both the 50cc and 70cc hearts, and in so doing, eliminate a significant number of the unintended alarms that the current device has been experiencing. The upgrade will also ensure that even in extreme cases of hypervolemia and hypertension, the device will still display correct measurements.
The software upgrades will be implemented as the current fleet of drivers is returned to the company for routine maintenance and servicing. Customers can reasonably expect that drivers shipped after May 1st of this year will include the new, upgraded software. Drivers with the upgraded software will bear serial numbers ending with the letter “A”.
The Freedom Driver is intended for use with the SynCardia temporary Total Artificial Heart (TAH-t) in clinically stable patients, both of which have been approved by the FDA. Together, they act to replace the full functions of a failed or failing heart for patients experiencing biventricular heart failure. The Freedom Driver also offers greater mobility and quality of life to patients who meet the discharge criteria, allowing them to spend more quality time at home with their families, while waiting for a matching donor heart.
Questions about the software upgrades should be directed to the clinical support team at firstname.lastname@example.org