Mitre Medical Corp.
To evaluate the safety and performance of the Mitral Touch System to treat mitral insufficiency in patients who are to undergo cardiac surgery with either a sternotomy or thoracotomy who present with moderate to severe ischemic or functional mitral regurgitation.
The Mitral Touch Systems is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.
Inclusion Criteria: * Moderate or greater (2+) ischemic * Functional Mitral regurgitation by 2D echocardiography using an integrative method * Patient is scheduled for cardiac surgery (e.g. CABG including patients on the waiting list for Heart Transplantation) * Patient is 22 years of age or older * Patient is willing and able to sign Informed Consent Form * Within 90 days patients should be on stable optimally uptitrated medical therapy recommended according to current guidelines23 as standard of care for heart failure therapy in the United States Exclusion Criteria: * Any evidence of stru…
The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.
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