The US Food and Drug Administration (FDA) has given Kips Bay Medical approval to enrol additional US patients in the eMESH I clinical feasibility trial of its eSVS Mesh.
In its initial approval, the FDA indicated that it would allow a staged enrolment within the United States, starting with five patients at up to four sites in the United States. The FDA has now increased the approved number of patients from five to 15.
The eMESH I clinical feasibility trial is a multicentre, randomised study of external saphenous vein support using Kips Bay Medical’s 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 support device during coronary artery bypass surgery. The company expects to enrol 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 a pivotal trial in the USA.
Kips Bay Medical announced it will provide six month follow-up angiograms on the first ten patients, from the USA and Europe combined, for the FDA to review. If the FDA determines that these angiograms are acceptable, Kips Bay Medical expects to receive the approval from the FDA to enrol the remaining US patients.