Kips Bay Medical (KIPS): Feasibility Clinical Trial in Europe and Recruiting of U.S. Sites
Kips Bay Medical, Inc. ( KIPS ) announced on August 22nd/2012 that its U.S. feasibility trial (eMESH I) of the eSVS Mesh has commenced in Bern, Switzerland and anticipates first implants and enrollments under this study to begin the week of September 2, 2012.
The objective of the eMESH I study remains the demonstration of initial safety and performance of the Kips Bay Medical eSVS Mesh sufficient to allow the FDA to approve an IDE for a pivotal study.
Also, KIPS has begun the process of responding to the FDA disapproval of its most recent IDE Application received on August 17, 2012.
Kips Bay Medical is gathering the necessary information and will provide it to the FDA within 30 days in an amended IDE Application
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