Kips Bay Medical has treated the first US patient in a multi-center, randomized eMESH I clinical trial using its extravascular nitinol (nickel titanium alloy) prosthesis.
The prosthesis, eSVS Mesh, is used as an external saphenous vein graft (SVG) support device while performing coronary artery bypass graft (CABG) surgery in patients with atherosclerotic disease and for preventing SVG from closing.
The implant was performed at Northeast Georgia Heart Center in Gainesville, Georgia, US.
The eSVS MESH improves the structural characteristics and long-term performance of the graft, when placed on the outside of SVG during CABG surgery, according to the company.
The feasibility trial, which will enroll up to120 patients from eight European and four US sites, will demonstrate 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 for performing a pivotal trial in the US.