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News Breaks | | | | August 22, 2012 | | 17:37 EDT |  | KIPS | Kips Bay Medical responding to FDA disapproval of most recent IDE application
Kips Bay Medical has begun the process of responding to the U.S. Food and Drug Administration’s disapproval of its most recent IDE Application received on August 17, 2012. The IDE Application filed on July 19, 2012 sought approval to add four U.S. sites to the feasibility trial described above. In the letter received August 17, the FDA has requested additional information on the pre-clinical design testing of the eSVS Mesh that was referenced in the IDE Application. The Company is gathering the necessary information and will provide it to the FDA within 30 days in an amended IDE Application. If the FDA approves the amended IDE Application, U.S. physicians will then be allowed to begin enrolling patients. Kips Bay Medical has already contacted prominent U.S. heart centers that are taking steps to secure internal approvals of their institutional review boards and administration/finance departments to participate in the study. | |
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