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News

Kips Bay Medical receives FDA approval to commence clinical study of the eSVS Mesh in the USA

Kips Bay Medical : 12 November, 2012  (Company News)
Kips Bay Medical receives approval with conditions of Kips Bay Medical's Investigational Device Exemption to include four US study sites in the eMESH I clinical feasibility trial of the company's eSVS Mesh.


The study commenced in Bern, Switzerland on August 31, 2012.



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 CABG Surgery. The objective of the study is to demonstrate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft (SVG) support device during coronary artery bypass (CABG) procedures sufficient to allow the FDA to approve an IDE for a pivotal study in the USA. The company expects to enroll up to 120 patients at eight European and four US sites.



In its approval, the FDA indicated that it will allow a staged enrollment within the United States starting with five patients. Kips Bay Medical will provide the six-month follow-up angiogram data of five US patients or 10 outside the United States and US patients combined, as well as additional data the FDA requested, for the FDA to review prior to approving the remaining 35 US patients initially requested by the company. There is, however, no assurance that the FDA will provide such approval.


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