FDA Grants Ethicon Endo-Surgery Approval of Its IDE Application to Commence Study of Notes T... (verall healthcare industry said Karen L...)

FDA Grants Ethicon Endo-Surgery Approval of Its IDE Application to Commence Study of Notes Toolbox(TM)

Date:4/22/2009

verall healthcare industry," said Karen Licitra, Company Group Chairperson, Ethicon Endo-Surgery. "An integral piece to advancing NOTES surgery responsibly is ensuring surgeons have the proper technology at hand. This IDE represents an important step for Ethicon Endo-Surgery in fulfilling that need by pursuing a NOTES-specific indication for the NOTES Toolbox."

The four sites participating in the trial include Northwestern University Feinberg School of Medicine; University of California - San Diego Medical Center; The Ohio State University Center for Minimally Invasive Surgery; and the University of Missouri University Hospital. Each clinical trial site will investigate one of four methods: transgastric (through the mouth) and transvaginal (through the vagina) cholecystectomies and transgastric and transvaginal diagnostic peritoneoscopies.

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.

Ethicon Endo-Surgery is actively leading the development of NOTES through research to determine the most appropriate tools and technologies that may enable safe and effective NOTES surgery. The Ethicon Endo-Surgery NOTES Toolbox devices are investigational devices that have not been approved for marketing in the U.S.

More information can be found at www.ethiconendo.com.

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