Kips Bay Medical has obtained the US Food and Drug Administration (FDA) approval for including more patients and study locations in the eMESH I clinical feasibility trial in the US.
The eMESH I clinical feasibility study is designed to evaluate the initial safety and performance of the eSVS Mesh for use as an external saphenous vein graft (SVG) support device during coronary artery bypass surgery.
The FDA, in its initial approval, has indicated that it would allow a staged enrollment within the US, starting with 15 patients at up to four sites in the country.
The agency has now approved to increase the number of US patients from 15 to 27 and increase the allowed number of US sites from four to 10. Currently, 12 patients have been enrolled in the study.
Additionally, 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.
These changes are intended to reduce the risk of early graft occlusion, make it easier to implant the eSVS Mesh and reduce procedural costs.
Kips Bay Medical is likely to work with its European and US sites to use its eSVS mesh on all patients going forward. The company anticipates using the data from this study as the basis for requesting an investigational device exemption to conduct a larger pivotal trial in the US.
The eSVS Mesh is a highly flexible, kink-resistant tubular prosthesis made of knitted nitinol wire. It fits externally over the saphenous vein and is designed to provide strength and support for improving graft patency.
The device is indicated for improving saphenous vein bypass graft patency in patients undergoing coronary artery bypass graft procedures utilizing autologous saphenous vein grafts with external diameters from 3.6-7.0mm and double wall thicknesses less than 1.4mm.