Item 8.01 Other Events

On November 8, 2012, Kips Bay Medical, Inc. (the "Company") issued a press release announcing that the U.S. Food and Drug Administration has granted approval with conditions of the Company's Investigational Device Exemption to include four U.S. study sites in the "eMESH I" clinical feasibility trial of its eSVS Mesh. The full text of the press release is set forth in Exhibit 99.1 attached hereto and is incorporated by reference in this Current Report on Form 8-K as if fully set forth herein.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits: 99.1 - Press Release dated November 8, 2012

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