The US Food & Drug Administration (FDA) has granted approval to Kips Bay Medical to include four US study sites in the eMESH I investigational device exemption trial of its eSVS Mesh.
The eMESH I clinical feasibility trial is a multicentre, randomised study of external saphenous vein support using the eSVS Mesh in coronary artery bypass (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 (SVG) support device during CABG procedures sufficient to allow the FDA to approve an investigational device exemption for a pivotal study in the USA. The company expects to enrol up to 120 patients at eight European and four US sites.
In its approval, the FDA indicated that it will allow a staged enrolment 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 to review prior to approving the remaining 35 US patients initially asked by the company. According to Kips Bay Medical, “there is, however, no assurance that the FDA will provide such approval.”