Introducing the SEDASYS® System

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About the SEDASYS® Computer-Assisted Personalized Sedation System

The SEDASYS® System is the first Computer-Assisted Personalized Sedation (CAPS) system. It is designed to enable physician-led teams to administer minimal-to-moderate propofol sedation by integrating comprehensive patient monitoring and drug delivery personalized to the needs of each patient. The System minimizes the risks associated with oversedation by continually detecting and responding to patient vital signs.

The SEDASYS® System is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal-to-moderate sedation, as defined by the American Society of Anesthesiologists (ASA) Continuum of Depth of Sedation, in ASA physical status I and II patients =18 years old undergoing colonoscopy and esophagogastroduodenoscopy (EGD) procedures.

In introducing this first-of-its-kind technology, the SEDASYS® System will only be offered to facilities where an anesthesia professional is immediately available to the user for assistance or consultation as needed. 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 when administered using computer-assisted personalized sedation systems including: pharmacology of propofol, identification of high risk patients, recognition of progression of levels of sedation and actions necessary to return a patient to intended levels of sedation, use of capnometry and the determination of adequate ventilation and management of airway obstruction and hypoventilation.

The pivotal clinical study demonstrated that the System reduces the risks associated with oversedation. 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 benzodiazepines and opioids.1

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 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.

The SEDASYS® System has the potential to redefine the way sedation is administered for eligible patients. In addition, the technology will empower health care facilities to more effectively use their limited resources to deliver greater value in the increasingly resource-constrained U.S. health care environment.

Learn more about this new option for delivering sedation.

  Download the Product Overview Brochure (PDF)
  Watch the SEDASYS® System Overview Video

View the Essential Product Information (PDF)

Read a white paper discussing myths about the SEDASYS® System (PDF)

1Pambianco DJ, Vargo JJ, Pruitt RE,et al. Computer-assisted personalized sedation for upper endoscopy and colonoscopy:a comparative, multicenter randomized study. Gastrointest Endosc. 2011;73:765-772.

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