Ethicon Endo-Surgery, a Johnson & Johnson company, announced that the FDA granted PMA approval for its SEDASYS device, the first computer-assisted personalized sedation (CAPS) system for use by clinicians in the endoscopy suites.
In other words, the system aims to replace anesthesiologists and CRNAs with computerized technology to administer propofol and to monitor minimal-to-moderate sedation in patients undergoing upper and lower endoscopies. According to the company, only ASA class I and II patients are eligible to receive propofol via SEDASYS.
According to Johnson & Johnson:
By integrating state-of-the-art drug delivery and patient monitoring, the SEDASYS® System enables physician/nurse teams to deliver personalized sedation. It automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The SEDASYS® System monitors and records patient vital signs and additional parameters, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness….
…In introducing this first-of-its-kind technology, the company will offer the SEDASYS System to facilities where an anesthesia professional is immediately available for assistance or consultation. In addition to receiving device-specific training, the member of the physician-led team who is administering sedation must have training in the management of cardiorespiratory effects of propofol. The SEDASYS System is expected to be introduced on a limited basis beginning in 2014. The company will collaborate with the gastroenterology, anesthesiology and nursing communities to successfully integrate the SEDASYS System, and conduct two post-approval studies to monitor the use of the technology in actual clinical practice….
Data included in the company’s PMA application demonstrated that the System reduces the risks associated with over sedation because patients who received sedation with the SEDASYS System experienced fewer and less significant oxygen desaturation events than patients in the control group who received traditional sedation with benzodiazapines and opioids. The data also demonstrated that patients sedated with the SEDASYS System recovered faster than the control group, with 99 percent recovered from the effects of sedation within 10 minutes, and that patients were highly satisfied. In addition, physicians were significantly more satisfied with administration of sedation they provided to patients in the SEDASYS System group compared to sedation provided to patients in the control group.