Medical Device Daily Executive Editor
Diagnostic procedures range from easy and unobtrusive (maybe just a quick nasal swab, that's all), to highly obtrusive and uncomfortable (read, colonoscopy) this spectrum largely determining patient willingness to pursue them.
The result for colonoscopy: many of those reading this story (or many they know) keep putting off this procedure, or avoid it altogether.
The answer to this problem is improved comfort, perhaps through improved sedation and something better than the current use of a pain-killing bolus or opioid injection, according to Mike Gustafson, executive director of Ethicon Endo-Surgery (Cincinnati).
Gustafson told Medical Device Daily that the necessary improvement is currently on deck, with the company's recent filing of an FDA application for premarket approval of its SEDASYS system, which it is billing as "the first computer-assisted personal sedation (CAPS) system," primarily targeting colonoscopy but also esophageal procedures or other such diagnostics with fairly high discomfort levels for the patient.
Rather than simply offering sedation more flexibly, when needed, the system provides continuous monitoring of vital signs of the depth of sedation.
And perhaps more importantly, from both a patient compliance and marketing point of view, Ethicon Endo-Surgery is seeking regulatory labeling for the SEDASYS that enables its use by a physician or nurse and not requiring the presence of an anesthesiologist, thus greatly expanding its potential uptake by providers and acceptance by patients.
Demonstrating a sensitivity to over-claiming for a product not yet approved, Gustafson didn't tout a variety of claims for SEDASYS, but told MDD: "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, with 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.
Surprisingly, 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 though perhaps 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."
Along this same line of thinking, the company will be developing a specific training program and protocols for system use as the product is under FDA review.
Without providing firm expectations, Gustafson didn't argue with a possible approval by the FDA later this year and product roll-out in 2009, calling that possible timeline "reasonable."
He said that Ethicon Endo-Surgery has put nine years and a "significant amount of resources" though declining to disclose the specific dollar amount into DESASYS development.
"Price studies," he said also, are ongoing,
"It's all about the early detection and treatment of colon cancer," Gustafson said. Compliance with that type of testing, he noted, is unacceptably low, at a rate of 20% to 25%, with the company hoping that use of the SEDASYS could push this to as high as 75%.
And the requirement to seek PMA approval helps to underline the system's uniqueness in the sector.
While Gustafson said that the company is hoping that standard anesthesia codes will cover use of the SEDASYS, he asserted, "There is no technology like this today."