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Ethicon Endo-Surgery Sedasys System Gets Canadian Approval, EU CE Mark

Ethicon Endo-Surgery's Sedasys System, the first computer-assisted personalized sedation (CAPS) system, was granted a CE mark for the European Union for routine colonoscopy and screening of the upper gastrointestinal tract (EGD procedures). In addition, Health Canada had granted regulatory approval for the Sedasys System for use by healthcare professional teams during routine colonoscopy.

Ethicon Endo-Surgery said that the Sedasys System, which is featured in poster presentations at Digestive Disease Week (DDW) 2010, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient’s needs.

The posters describe post-hoc analyses of data from a multi-center, prospective, randomized, controlled pivotal trial of 1,000 patients that compared the safety and effectiveness of the Sedasys System to current standard of care drugs benzodiazepines and opioids for sedation during endoscopic procedures (colonoscopy and EGD).

Karen Licitra, company group chair and worldwide franchise chair at Ethicon Endo-Surgery, said: “We are excited by these regulatory approvals and the opportunities they provide to bring the Sedasys System to the Canadian and European markets. We believe the Sedasys System has the potential to improve the sedation experience for patients and clinicians during routine colonoscopy procedures, and we look forward to the launch of the System in these markets, as early as the end of this year.”