Conditions of approval recommended by the committee included that the SEDASYS System only be used in adult patients age 70 and under. The final decision regarding approval of the device will be made by the FDA.
The SEDASYS System, the first computer-assisted personalized sedation system, automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by continual monitoring and recording critical patient vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.
In a recent study, patients who received sedation with the SEDASYS System experienced fewer and less significant oxygen desaturation events, a clinical sign of over-sedation, than patients sedated with the current standard-of-care drugs — benzodiazepines and opioids.
Read the Ethicon Endo-Surgery release on the SEDASYS System approval.
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