by
Joan Trombetti, Writer | March 31, 2008
Ethicon Endo-Surgery
develops and markets
advanced medical devices
for minimally invasive
and open surgical
procedures.
Ethicon Endo-Surgery has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS(TM) System, which is the first computer-assisted personalized sedation (CAPS) system.
The System is meant to be used by physicians and nurse teams to administer minimal to moderate amounts of propofol sedation to patients that are
being screened and diagnosed for colorectal cancer (colonoscopy). It will also be used for disorders of the upper gastrointestinal tract (EGD).
For routine colonoscopy or EDG procedures, physicians prefer the sedative propofol (also known as DIPRIVAN(R)), which produces rapid onset and quick recovery for patients.
The PMA submission also includes results from a multi-center prospective, randomized controlled trial of 1,000 patients that compared the safety and effectiveness of the SEDASYS™ System to the current standard of care for sedation in routine endoscopic procedures - physician-administered benzodiazepine and opioids. The clinical trial was conducted in March 2007 through October 2007 at several locations in the U.S.
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.
SEDASYS is a trademark of Ethicon Endo-Surgery
DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies. For further information go to www.ethiconendo.com
