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News

Mayo Clinic performs first eSVS Mesh Implant in the USA

Kips Bay Medical : 03 May, 2013  (Application Story)
Mayo Clinic performs the first implant of a Kips Bay Medical's eSVS Mesh at the organisation's Rochester, Minnesota facility in the USA.


The implant was performed as part of the Kips Bay Medical eMESH I clinical feasibility trial currently being conducted for the US FDA in a number of preeminent cardiac surgery centres in both Europe and the United States.



Villafaña said "We are honoured to have such a prestigious centre as the Mayo Clinic participating in our eMESH I trial."



The eMESH I clinical feasibility trial is a multi-centre, randomized study of external saphenous vein support using Kips Bay Medical’s eSVS Mesh in coronary artery bypass graft (CABG) surgery. The objective of this study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft support device during CABG surgery. The company expects to enroll up to 120 patients at eight European and four US 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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