Kips Bay Medical (NASDAQ: KIPS) announced that the first patients have been enrolled in the Company sponsored eSVS MESH Post-Market Randomized Study at the University Hospital Kiel in Germany by Dr. Tim Attmann who stated, “We are pleased to have been the first center to start enrolling patients in this important post-market study. These two patients were typical surgery candidates with symptomatic multiple coronary artery disease, each requiring three (3) coronary artery bypass grafts.”
The intent of the post-market study is to evaluate short term and long term patency of saphenous vein grafts treated with the eSVS MESH during coronary artery bypass surgery. The clinical studies will involve several prestigious cardiovascular centers across Europe. The data from these studies will be used to further support the marketing of and reimbursement requirements for the eSVS MESH internationally.
Commenting on the start of the Study, Professor, Dr. Joachim Cremer, Chief, Department of Cardiovascular Surgery, at the University Hospital Kiel stated, “The eSVS Mesh concept of supporting the vein graft to prevent over-expansion and subsequent vessel injury is very intriguing and could lead to improved patient outcomes and that’s what this study is designed to demonstrate.” Professor Cremer and his colleagues had previously participated in the multicenter international clinical trial of the eSVS MESH which led to CE Mark approval in May 2010.
This first study will be prospective multi-center, randomized, controlled, clinical study of up to 200 patients, designed to evaluate the short and long term patency of the eSVS MESH compared with a an untreated control graft. In this study each patient will have both a saphenous vein graft treated with the eSVS MESH and untreated graft implanted during their coronary artery bypass surgery. The location of the saphenous vein graft treated with the eSVS MESH will be randomized to either the right or circumflex coronary artery bed. Patency will be assessed at 6 months and 2 years post implant.