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Objective: The eSVS Mesh is a knitted nitinol wire external support intended for use to improve patency of saphenous vein grafts (SVGs) in CABG surgery. It is designed to provide radial support to prevent SVG dilatation, to reduce graft diameter to more closely match target coronary artery diameter and to provide a uniform graft lumen to help improve blood flow characteristics and mitigate the development of stenosing neointimal hyperplasia (NIH), a primary cause of mid-term graft failure. The object of the study was to assess comparative graft patency at 9-12 month and safety of the e-SVS Mesh support device for major adverse clinical events (MACE: death, stroke, MI, target lesion revascularization) at 30 days.
Methods: From August 2008 through July 2009, 90 patients were enrolled in a prospective, global multi center, randomized, controlled clinical trial and received both an eSVS Mesh and Control SVG. Each patient was implanted with one eSVS Mesh graft and one control graft and randomized to site, thus the patients served as their own control. The eSVS Mesh diameters were 3.0, 3.5, 4.0 and 4.5 mm.
Results: Overall MACE rate was 4.4% comparable to the Objective Performance Criteria (OPC) for CABG of 9.4%. There were no deaths, two strokes (2.2%), and two MI events (2.2%). 73 patients (81%) presented for angiography during the 9-12 month interval. The 3.0 Mesh proved to be too aggressive in downsizing and has been eliminated. One site experienced technical difficulties with the device and had substantially lower eSVS patency. Excluding this site and 3.0mm data, the angiographic patency of eSVS Mesh and Control SVG’s is statistically equivalent.
• 3.5/4.0/4.5 mm Mesh: Patency of 73% (24/33), 95% CI of 54%-87%
• Controls: Patency of 76% (25/33), 95% CI of 58%-89%
To date, 20 subjects, who had angiographically patent eSVS Mesh SVG’s during the 9-12 month period, have presented for the 24-36 month imaging and all grafts remain patent.
Conclusion: Angiographic imaging studies indicate that when the eSVS Mesh is patent at 9-12 months post implant, patency is maintained a 24-36 months post implant. CE Mark approval granted. Post market studies continue.