Ethicon Gains PMA For SEDASYS; Opens New Opportunity In GI Medicine

Article preview from Medtech Insight - May 2013

Ethicon finally received FDA approval in May for its SEDASYS System, a computer-assisted personalized sedation system that allows physician-led teams to safely administer the anesthetic agent propofol during certain gastroenterology procedures, including colonoscopy. The approval opens up a whole new product category for the company with a market potential of 15 million procedures in the US alone.

Ethicon Gains PMA For SEDASYS; Opens New Opportunity In GI Medicine

Article preview from Medtech Insight - May 2013

After a long and protracted regulatory process, Sedasys, a division of Ethicon Endo-Surgery Inc./Johnson & Johnson, finally received US Food and Drug Administration premarket approval in early May for the SEDASYS System, a computer-assisted personalized sedation (CAPS) technology designed to allow trained physician-led teams to safely administer the anesthetic agent propofol to healthy adults undergoing routine colonoscopy and upper endoscopy procedures. The technology, which integrates physiological monitoring and drug delivery through a computer interface, is a whole new product category for the company and has a market potential of 15 million procedures in the US alone.

FDA rejected the company’s initial application for SEDASYS in 2010 after anesthesiologist groups expressed concerns about the safety of the approach and the Agency questioned whether the company had appropriate data and training protocols to back up the safety claims.Ethicon then began a rarely used appeals process, and it ultimately persuaded the FDA to reconsider its PMA without a formal appeal.

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