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March 17, 2014
07:11 EDTKIPSKips Bay Medical announces FDA approval for U.S. expansion of eMESH I study
Kips Bay Medical announced that the FDA has granted an approval for Kips Bay Medical to include more U.S. patients and U.S. study sites in its "eMESH I" clinical feasibility trial of its eSVS Mesh. In its initial approval, the FDA indicated that it would allow a staged enrollment within the United States, starting with 15 patients at up to four sites in the United States. The FDA has now increased the approved number of U.S. patients from 15 to 27 and increased the allowed number of U.S. sites from four to 10. In addition, the FDA has also approved a combination of changes in the application of the eSVS Mesh to the saphenous vein graft and to the surgical implant technique for the eSVS Mesh treated graft. The changes are intended to reduce the risk of early graft occlusion, make it easier to implant the eSVS Mesh and reduce procedural costs.
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July 28, 2014
09:21 EDTKIPSKips Bay Medical announces first eSVS Mesh implant by Lenox Hill Hospital
Manny Villafaņa, chairman and CEO of Kips Bay Medical, announced that on July 17, Lenox Hill Hospital in New York City performed its first implant of an eSVS Mesh. This implant was performed as part of the Kips Bay Medical eMESH I clinical feasibility trial currently being conducted for the FDA in a number of preeminent cardiac surgery centers in both Europe and the United States. The company expects to enroll up to 120 patients at eleven European and seven U.S. sites and further expects to use the data from this study as the basis for the filing of a request for an investigational device exemption to perform a pivotal trial in the United States.

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