Personalized Propofol Sedation System Seeks FDA Approval

SEDASYS™ System Designed for Minimal to Moderate Propofol Sedation Delivery

CINCINNATI -- Ethicon Endo-Surgery announced that the company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS™ System, the first computer-assisted personalized sedation (CAPS) system.

The SEDASYS™ System is intended for use by physician/nurse teams to administer minimal to moderate propofol sedation to patients undergoing screening and diagnostic procedures for colorectal cancer (colonoscopy), and disorders of the upper gastrointestinal tract (EGD). For routine colonoscopy or EGD procedures, physicians prefer the sedative propofol (also known as DIPRIVAN®), which produces rapid onset and quick recovery for patients.ⁱ

The PMA submission 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 pivotal clinical trial was conducted from March 2007 to October 2007 at eight locations in the U.S.

Reference
(i) American Gastroenterological Association press release, March 8, 2004. "Gastroenterological Societies Reach Consensus on Recommendations for Sedation During Endoscopic Procedures"

Source: Ethicon Endo-Surgery

Share this article: Email, Slashdot, Digg, Del.icio.us, Yahoo!MyWeb, Windows Live Favorites, Furl
Add this article feed to: RSS, My Yahoo, Newsgator, Bloglines

Read Comments [0]