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March 17, 2014
07:11 EDTKIPSKips Bay Medical announces FDA approval for U.S. expansion of eMESH I study
Kips Bay Medical announced that the FDA 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 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.
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August 12, 2014
09:20 EDTKIPSKips Bay Medical provides feasibility study update
Enrollment in the eMESH I clinical feasibility trial has continued, although at a slower than expected pace during Q2. As of August 1, 56 patients had been enrolled in the eMESH I clinical feasibility trial. Kips Bay attributes part of this slowness to a delay in its receipt of the CE Mark approval incorporating the new implant technique approved by the FDA for use in the feasibility trial. In addition, organizational changes within two of the U.S. study sites delayed internal approvals required for those sites to resume the enrollment of study patients. In March, the FDA approved a combination of changes in the application of the eSVS Mesh to the saphenous vein graft, or SVG, and to the surgical implant technique for the eSVS Mesh treated graft. These changes were based upon the company's consultations with medical advisors and several of the cardiac surgeons participating in the eMESH I clinical feasibility trial and the company's initial review of early results from the eMESH I trial. The changes are intended to reduce the variables in the study and the risk of early graft occlusion. Kips Bay also believes these changes will simplify the process of applying and implanting the eSVS Mesh thereby reducing procedural costs. Also in March, the company requested an update of its CE Mark approval to incorporate the changes in the application of the eSVS Mesh to the saphenous vein graft and to the surgical implant technique that were approved by the FDA for use in the eMESH I clinical feasibility trial. Based upon recent communications with its notified body, the company believes that the review process is near completion and that Kips Bay will receive the updated approval during the third quarter. Kips Bay believes that the CE Mark review process has taken longer than the company had anticipated due to a backlog in the workload of the company's notified body. Currently, seven European study sites are now able to enroll study patients in the eMESH I clinical feasibility study, however, they may not use the new implant technique until the company receives an updated CE Mark approval. Three additional international sites have received ethics committee approval and are in the process of finalizing clinical trial agreements in order to begin enrollment, which is expected to commence during Q3.

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