US-based medical device company Kips Bay Medical has implanted the first US patient in a multi-centre, randomised clinical study of its eSVS Mesh.
The extravascular nitinol (nickel titanium alloy) prosthesis, which was implanted at Northeast Georgia Heart Centre in Gainesville, Georgia, US, is used as an external saphenous vein graft (SVG) support device while performing coronary artery bypass graft (CABG) surgery in patients with atherosclerotic disease.
Northeast Georgia Heart Centre minimally invasive valve reconstructions surgeon Dr Alan Wolfe said that in patients with atherosclerotic disease, the most significant problem is bypass graft closure.
"The eSVS Mesh device is designed to prevent saphenous vein grafts from closing," Wolfe said.
The eSVS MESH improves the structural characteristics and long-term performance of the graft, when placed on the outside of the SVG during CABG surgery, according to the company.
The feasibility trial, eMESH I, will enrol up to 120 patients from eight European and four US sites to assess the initial safety and performance of the eSVS Mesh for supporting external SVG.
The company said it will use the study data to submit an investigational device exemption application seeking approval from the US Food and Drug Administration to perform a pivotal trial in the US.
Kips Bay provides therapeutic vascular technologies to better treat cardiovascular diseases, and develops new solutions to advance, refine and improve cardiac surgery.