SEDASYS, a division of Ethicon, itself part of J&J, is releasing the SEDASYS Computer-Assisted Personalized Sedation (CAPS) System in the U.S. market. The device is intended for delivery of propofol (1% (10 mg/mL) injectable emulsion) by non-anesthesiologist clinicians when performing colonoscopy and esophagogastroduodenoscopy procedures.
The technology allows administration of minimal to moderate amounts of propofol during upper and lower GI endoscopies and for monitoring of patient sedation. According to the company, only adult ASA class I and II patients are eligible to receive propofol via SEDASYS.
The SEDASYS System precisely integrates comprehensive physiological monitoring and drug delivery for sedation personalized to the needs of each patient. Clinical data shows the SEDASYS System reduces the risks associated with over-sedation because patients who received sedation with the 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 faster patient recovery — 99 percent of patients recovered from sedation within 10 minutes. In addition, physicians were significantly more satisfied with administration of sedation they provided to patients in the SEDASYS System group.
The device received FDA approval in May of last year.
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