Ethicon Endo-Surgery Announces Pivotal Trial for Innovative Device to
Deliver Propofol Sedation by Physician/Nurse Team for Endoscopy Procedures
New Economic Study Results Presented at Digestive Disease Week (DDW)
Indicate the Need for Increased Colonoscopy Screening for Colorectal Cancer
Prevention Should Be a High Public Health Priority
WASHINGTON DC, DDW 2007 ANNUAL MEETING (May 22, 2007) - Ethicon
Endo-Surgery today announced the commencement of the company’s pivotal
clinical trial to measure the safety and effectiveness of an investigational
computer-assisted personalized sedation device (CAPS) designed to enable more
predictable and personalized delivery of propofol by a physician/nurse team
for routine endoscopy procedures. In addition, a new study funded by Ethicon
Endo-Surgery, “The Clinical and Economic Impact of Increased Colonoscopy
Screening in the United States: A Computer Simulation of a Markov Process,”
presented today at DDW by Dr. Won Chan Lee of Abt Associates, Inc., showed
that increasing colonoscopy screening rates in the eligible population
increases early detection of colorectal cancer (CRC) and reduces mortality.
Feasibility studies of this CAPS device, completed last year, demonstrated its
ability to facilitate the administration of minimal to moderate propofol
sedation appropriate to individual patient needs, while achieving high
clinician and patient satisfaction, and rapid recovery times. i,ii
Computer-assisted personalized sedation is a new category of sedation that
uses computerization to personalize drug delivery based on the individual
patient’s physiology. The pivotal study is a prospective, randomized and
controlled study of 1,000 patients at up to 12 sites comparing this first
computer-assisted personalized sedation device to the current standard of care
for routine EGD and colonoscopy procedures. Effectiveness will be assessed
based on clinician and patient satisfaction and sedation recovery time, while
safety will be determined by the incidence, duration and depth of desaturation
and the amount of time subjects spend in deep sedation/general anesthesia.
Trial sites will encompass academic centers, ambulatory surgery centers and
physician offices. Patient enrollment is currently taking place and the trial
is expected to be completed by the fourth quarter of 2007. Ethicon
Endo-Surgery intends to submit the pivotal results to the FDA in a PreMarket
Approval (PMA) submission.
"At the present time, propofol-mediated sedation is used in more than 25
percent of endoscopic procedures in the United States and this number
continues to grow, said Lawrence B. Cohen, M.D., Associate Clinical Professor
of Medicine, Mount Sinai School of Medicine. “Finding an on-label solution for
safe propofol delivery by gastroenterologists is imperative. By providing
patients with the appropriate level of sedation and adequate comfort, we will
improve patient compliance with colonoscopy screening and surveillance.
Ethicon Endo-Surgery’s device is the first in the category of
computer-assisted personalized sedation that utilizes computerization to
increase the predictability and reliability of sedation delivery. It combines
continuous physiological monitoring and the delivery of propofol through a
computer interface to facilitate precise and personalized sedation. The system
is designed for use by a physician/nurse team for routine EGD and colonoscopy
procedures.
The investigational system continually monitors and records seven patient
parameters including oxygen saturation, respiratory rate, heart rate, blood
pressure, end-tidal carbon dioxide, patient responsiveness and ECG. It
delivers oxygen and automatically reacts to signs of over-sedation (oxygen
desaturation and low respiratory rate/apnea) by stopping or reducing propofol
delivery, increasing oxygen delivery and automatically instructing patients to
take a deep breath. The system is an investigational product limited by U.S.
law to investigational use only.
“Results from previous clinical studies have been promising – there have been
no device-related adverse events, the physician/nurse teams easily operated
the device to deliver propofol, and there was high physician and patient
satisfaction. We are eager to expand the testing with our pivotal trial,” said
Michael Gustafson, Executive Director, Ethicon Endo-Surgery. “Ethicon
Endo-Surgery is committed to colon cancer prevention, screening and treatment
and is ideally suited to deliver new solutions and advance the science of
sedation.”
Propofol (also known as DIPRIVAN®) is considered a preferred sedative due to
its rapid onset, and quick, clear-headed recovery. Propofol labeling includes
a warning stating that the drug should be administered only by persons trained
in the administration of general anesthesia. However, today it is impractical
for anesthesia professionals to be present for all endoscopy procedures
requiring sedation. Pending favorable results from the pivotal trial, this
CAPS device can be approved with labeling that enables physician/nurse teams
to administer propofol during routine EGD and colonoscopy procedures. With
more accessibility to propofol, endoscopists may be able to conduct more
screenings and, as a result, accommodate the increasing demand for such
procedures.
According to Dr. Lee’s study, while the demands for colorectal cancer
screening are increasing, the screening rate remains well below the American
Cancer Society’s 2015 goal of 75 percent of the eligible population.iii
The results indicate that increasing screening rates in the eligible
population decreases the treatment costs related to late stage colorectal
cancer. In addition, a base case scenario in which the screening rate
increases from 40 percent to 80 percent demonstrates a decrease in incremental
costs per life year gained (LYG) from $10,484 to $7,914. The study further
concluded that ways to increase colonoscopy screening should be a public
health priority.
About DDW
DDW is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and the
Society for Surgery of the Alimentary Tract, DDW takes place May 19-24, 2007,
at the Washington Convention Center, Washington, DC. The meeting showcases
approximately 5,000 abstracts and hundreds of lectures on the latest advances
in GI research, medicine and technology. For more information, visit www.ddw.org.
About Ethicon Endo-Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets
advanced medical devices for minimally invasive and open surgical procedures,
focusing on procedure-enabling devices for the interventional diagnosis and
treatment of conditions in general and bariatric surgery, as well as
gastrointestinal health, gynecology and surgical oncology. More information
can be found at www.ethiconendo.com.
© Ethicon Endo-Surgery, 2007
DIPRIVAN® is a registered trademark of the AstraZeneca group of companies.
iMoerman A., Pambianco D.,
McRorie J., Martin J., Struys M., Feasibility Assessment of a Sedation
Delivery System To Administer Propofol for GI Endoscopy, Presented at American
Society of Anesthesiologists Annual Meeting 2006
iiPambianco D., Whitten C.,
Moerman A.,, Struys M., Martin J., McRorie J., Feasibility Assessment of
Computer-Assisted Personalized Sedation: A Sedation Delivery System to
Administer Propofol for Gastrointestinal Endoscopy, Presented at American
College of Gastroenterology Annual Meeting 2006
iiiLee W.C., Yu-Chen Y.,
Altzinger C.B., Pashos C.L., Clinical and Economic Impact of Increased
Colonoscopy Screening in the United States, A Computer Simulation of a Markov
Process, presented at DDW, 2007
