Ethicon division, Sedasys, has announced the U.S. launch of its SEDASYS® System, a Computer-Assisted Personalized Sedation (CAPS) system that enables trained physician-led teams to administer minimal-to-moderate propofol sedation to healthy patients undergoing routine colonoscopy or esophagogastroduodenoscopy(EGD) procedures.
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, patients who received sedation with the System having experienced fewer and less significant oxygen desaturation events than patients in the control group who received traditional sedation with benzodiazapines and opioids.
Data also demonstrates faster patient recovery, 99 percent of patients having 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 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 ASA Continuum of Depth of Sedation, in ASA physical status I and II patients ≥18 years old undergoing colonoscopy and EGD procedures. The U.S. FDA approved the SEDASYS System in May 2013 and in June 2014 granted approval for modifications to certain components based on technological advances the company had made over the last year.
The announcement was made at ANESTHESIOLOGY™ 2014, the Annual Meeting of the American Society of Anesthesiologists (ASA).
Virginia Mason is one of the health care institutions that have had clinicians complete the required training on the SEDASYS System and third party clinical training in the management of cardiorespiratory effects of propofol, and have incorporated the System into their program. The System is only used in settings where an anesthesia professional is immediately available for assistance or consultation as needed.
“Use of this technology is a continuation of our commitment to ensuring quality outcomes and patient safety, and to striving for an optimal patient experience,” said Otto Lin, MD, director, Quality Improvement, Digestive Disease Institute at Virginia Mason, a regional health care system in Seattle and the first to adopt the SEDASYS System.
“The SEDASYS System launch is proceeding as we planned. Institutions are embracing this new technology as a safe and effective method enabling physician-led teams to administer propofol sedation to their patients undergoing routine colonoscopy and upper endoscopy procedures,” said Paul Bruggeman, General Manager, Sedasys. “For the remainder of the year into 2015, we will continue our controlled launch and are excited to be a solution for facilities looking to deliver greater value in today’s increasingly resource constrained U.S. health care market.”
“Anesthesiologists typically use propofol to deliver deep sedation; however, the SEDASYS System targets minimal-to-moderate sedation. The System provides continuous monitoring and rapid safety responses if adverse sedation-related physiology is detected,” said Randy Hickle, MD, anesthesiologist and originator of the concept for the System. “The System enhances patient safety through four integrated elements – dosing restrictions, automated oxygen delivery, patient alarms and System status advisories.”