BB&T Executive Editor

Ethicon EndoSurgery has filed an FDA application seeking premarket approval for a system that it says will improve the systems of sedation used in colonoscopy — primarily apain-killing bolus or opioid injections — while also encouraging many more patients to undergo that assessment and other patient-unfriendly procedures.

Mike Gustafson, executive director of Ethicon Endo-Surgery, told Biomedical Business & Technology that the company's SEDASYS system is "the first computer-assisted personal sedation (CAPS) system," primarily targeting colonoscopy but also esophageal procedures or other such diagnostics with fairly high patient discomfort levels.

Rather than simply offering sedation more flexibly, when needed, the system provides continuous monitoring of vital signs of the depth of sedation.

Importantly also, the company is seeking regulatory labeling that enables use of the system by a physician or nurse and not requiring the presence of an anesthesiologist, thus expanding its potential uptake by providers and acceptance by patients.

Gustafson didn't list a variety of claims for SEDASYS, but told BB&T, "What I can tell you is that our feasibility studies in the U.S. and Belgium demonstrated that [SEDAYSYS] is able to deliver very precise and personalized delivery of propofol [also known as DIPRIVAN] by the nurse or physician."

Propofol is the sedative drug to be used with the system, the company emphasizing the system's provision of only "minimal to moderate" sedation in the targeted procedures.

The company's PMA submission includes results from a multi-center randomized trial of 1,000 patients that compared the safety/effectiveness of the SEDASYS to current sedation used in routine endoscopic procedures — physician-administered benzodiazepine and opioids. The study assessed safety based on Area Under the Curve (AUC) for oxygen desaturation, reflecting objective measurements incorporating incidence, duration and depth of oxygen desaturation and the risk for over-sedation.

The trial found SEDASYS effective based on level of sedation, sedation recovery time and clinician and patient satisfaction, without the aid of an anesthesia professional.

Gustafson said that the concept "was originally the idea of an anesthesiologist, and we have had a number of marvelous anesthesiologists actively involved" in development — perhap not surprising in that anesthesiologists aren't normally present for endoscopy and colonoscopy procedures but the ones most likely to understand the need.

Gustafson emphasized the system's ability to provide monitoring of the patient throughout the procedure. Tethered to the patient via IV, the system tracks seven physiology parameters, from blood pressure to respiratory activity and providing continuous data via what the company calls "a novel Automated Response Monitor."

Additionally, the system provides for verbal prompting of the patient through an earpiece, to monitor responses via the patients' ability to respond to these prompts (for instance, asking the patient to take a deep breath).

With any signs of over-sedation, the system can be shut down, or it can sense over-sedation and "proactively takes action, stops or reduces the delivery," Gustafson said. He added: "One of our focuses has been real practice and we've engaged human factor experts [in the development process]. We feel really good about SEDASYS from a human factor perspective."

Gustafson termed the possibility of product approval in late 2008 and roll-out in 2009 "reasonable," with the hope that standard anesthesia codes will cover use of the SEDASYS. He concluded: "There is no technology like this today."