Kips Bay Medical Receives Updated CE Mark Approval
Kips Bay Medical, Inc. (Nasdaq: KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting, or CABG, surgery, today announced that it has received an updated CE Mark approving use of a new surgical implant technique for its eSVS Mesh.
Feasibility Study Update
On August 20, 2014, the Company received an updated CE Mark approval from its notified body. This updated approval will allow the Company's European study sites to enroll patients in the Company's eMESH I clinical feasibility trial using 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 United States Food and Drug Administration (FDA) in March of this year.
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.
With this updated CE Mark approval, seven European study sites are now able to enroll study patients in the eMESH I clinical feasibility study using the new implant technique. 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 the third quarter.
Kips Bay currently has five study sites in the United States, which include the Mayo Clinic, the Cleveland Clinic, Emory University, the Lenox Hill Hospital and the Northeast Georgia Medical Center, that are recruiting patients for the trial, and one additional site is expected to be recruiting within the next 60 days.
The eMESH I clinical feasibility trial is a multi-center, randomized study of external saphenous vein graft (SVG) support using the Company's eSVS Mesh in coronary artery bypass grafting surgery. The objective of the eMESH I clinical feasibility trial is to demonstrate to the FDA the initial safety and performance of the eSVS Mesh for use as an external SVG support device during CABG surgery. If the feasibility trial is successful, the Company intends to use the data from this study as the basis for the filing of a request for an investigational device exemption, or IDE, to perform a larger pivotal study. The pivotal study is required to demonstrate clinical effectiveness and support a premarket approval application filing with the FDA seeking approval to sell the eSVS Mesh in the United States.
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