The following angiograms were collected during the eSVS® Mesh International Clinical Trial. We completed enrollment in this trial in July 2009, and as of May 1, 2010, all 90 patients have been implanted for 6 months or more, 89 patients have been implanted for nine months or more, and 71 patients have been implanted for 12 months or more. This trial formed the basis for our CE Mark application submitted in February 2010 and approved in May 2010.
These three example angiogram sets show that the saphenous vein grafts fitted with the eSVS® Mesh have smooth, regular lumens with good runoff, while the Control grafts (bare saphenous veins) show signs of dilatation, have irregular lumens, or have poor runoff. Implant details for these patients are:
- 13-month follow-up angiogram of a 76 year old male with a 3.5mm eSVS® Mesh graft to the distal right coronary artery (RCA) and a bare saphenous vein control graft to the 2nd obtuse marginal branch of the left circumflex artery (OM2)
- 13-month follow-up angiogram of a 58 year old male with a 3.5mm eSVS® Mesh graft to the right posterior descending artery (R-PDA) and a bare saphenous vein control graft to the 1st obtuse marginal branch of the left circumflex artery (OM1)
- 9-month follow-up angiogram of a 60 year old male with a 3.5mm eSVS® Mesh graft to the 1st obtuse marginal branch of the left circumflex artery (OM1) and a bare saphenous vein control graft to an acute marginal branch of the right coronary artery (RCA)
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76 year old male with a 3.5mm eSVS® Mesh to RCA
58 year old male with a 3.5mm eSVS® Mesh to RCA
60 year old male with a 3.5mm eSVS® Mesh to Cx
The eSVS® Mesh is not available in the United States.