Kips Bay Medical:FDA Oks For U.S. Expansion Of EMESH I Clincal Feasibility Study

(RTTNews) - Kips Bay Medical Inc. (KIPS) announced that the United States Food & Drug Administration has granted an approval for Kips Bay Medical to include more U.S. patients and U.S. study sites in its "eMESH I" clinical feasibility trial of its eSVS Mesh.

In its initial approval, the FDA indicated that it would allow a staged enrollment within the United States, starting with 15 patients at up to four sites in the United States.

The FDA has now increased the approved number of U.S. patients from 15 to 27 (15 additional from the 12 enrolled to date) and increased the allowed number of U.S. sites from four to 10.

In addition, 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. The changes are intended to reduce the risk of early graft occlusion, make it easier to implant the eSVS Mesh and reduce procedural costs.

"We are very pleased with this expanded approval which allows the Cleveland Clinic, the Lenox Hill Hospital and other interested U.S. sites to become active and commence enrolling patients in our eMESH I clinical feasibility trial," commented Manny Villafaña, Founder, Chairman and CEO of Kips Bay.

The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein support using Kips Bay Medical's eSVS Mesh in coronary artery bypass or "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 or "SVG" support device during CABG surgery.

The company said it intends to work with its European and U.S. sites to use its newly approved implant technique on all patients going forward and further expects to use the data from this study as the basis for requesting an investigational device exemption to conduct a larger pivotal trial in the United States.

The eSVS Mesh is designed to be fitted like a sleeve on the outside of saphenous vein grafts to strengthen SVGs used in coronary artery bypass graft surgery. By strengthening the SVG and preventing the damaging expansion of the vein graft, the Company hopes to reduce or prevent the resulting injury which can lead to SVG failure and potentially costly and complicated re-interventions for patients undergoing CABG surgery.