VIOLA Post Market Surveillance Clinical Protocol

Exclusion Criteria

• •1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
• •2. Prior clinical stroke less than one year before surgery
• •3. Pre-operative neurological deficits
• •4. Chronic atrial fibrillation
• •5. Aortic external diameter less than 25 mm measured intraoperatively
• •6. No proximal aortic anastomosis eligible for VIOLA use, assessed intraoperatively according to surgeon's discretion (E.G inadequate punch size, thin-walled aorta).
• •7. Symptomatic carotid disease
• •8. Acute MI within 24 hours of planned surgery
• •9. EuroScore II ≥ 4
• •10. Known allergy to nickel
• •11. Women of child bearing age
• •12. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.