EPIC: Bioprosthetic Valve for use in Aortic or Mitral Position

Study of:
The SJM Epic™ Valve is manufactured from selected porcine aortic valve cusps and is available in both the aortic and mitral positions. The valve is treated with an ethanol treatment intended to decrease calcification. The purpose of this study is to confirm the clinical safety and efficacy of the SJM Epic™ Valve for submission to the Food and Drug Administration (FDA) and other regulatory authorities as requested. Follow-up visits for patients enrolled in the study are conducted postoperatively at hospital discharge, at six months, 12 months and annually until study completion. Echocardiography assessments and blood samples are conducted at these follow-ups as well as preoperatively.

Vib R. Kshettry, MD

Dave Chose, RN

For more information about this study or the Cardiovascular Surgery Research program at the Minneapolis Heart Institute Foundation, please contact Dave Chose, RN at 612-863-3834.