Kips Bay Medical announced that the first patients have been enrolled in the eSVS Mesh post-market randomised study to evaluate short term and long term patency of saphenous vein grafts treated with the eSVS Mesh during coronary artery bypass surgery.
The eSVS Mesh is a nitinol mesh sleeve that, when placed over a saphenous vein graft during CABG surgery, is designed to improve the structural characteristics and long-term performance of the vein graft.
The first patients were enrolled at the University Hospital Kiel in Germany by Tim Attmann, he commented: “We are pleased to have been the first centre 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 coronary artery bypass grafts.”
“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 is what this study is designed to demonstrate,” said Joachim Cremer, chief, Department of Cardiovascular Surgery, at the University Hospital Kiel. Cremer and his colleagues had previously participated in the multicentre international clinical trial of the eSVS Mesh which led to CE mark approval in May 2010.
The eSVS Mesh is a prospective multicentre, randomised, 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 randomised to either the right or circumflex coronary artery bed. Patency will be assessed at six months and two years post implant.
The eSVS Mesh has CE mark and is currently being sold in six countries. The company estimates that since the beginning of its international clinical trial, over 250 eSVS Mesh devices have been implanted worldwide.