VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study

Functional MR is a frequent outcome of ischemic heart disease or dilated cardiomyopathy.
Patients with functional MR generally have normal valvular structures complicated by left
ventricular dysfunction. Left ventricular dysfunction will often create geometric
distortions that prevent complete leaflet coaptation, rendering the valve incompetent.
Changes that will induce functional MR may include (i) dyskinetic or akinetic wall segments,
(ii) dilation of the valve annulus or (iii) dilation of the left ventricle leading to
tethering of the chordae tendinae.

The iCoapsys Device is intended to treat patients with functional MR. The device is not
indicated for patients with diseased or damaged valvular structures caused by rheumatic
fever, degenerative diseases, endocarditis, infiltrative diseases or congenital disorders.

Key Inclusion Criteria:

- Grade 3 or 4 functional mitral valve regurgitation per 2D echocardiography.

- NYHA Class II and LVEF greater than or equal to 25% or NYHA Class III and LVEF
greater than or equal to 30%

Key Exclusion Criteria:

- History of pericarditis.

- Creatinine > 2.2 at the time of the procedure

- INR > 1.8 at the time of the procedure

- Prior pericardial intervention (including CABG, pericardiotomy or
pericardiocentesis).

- Any endovascular therapeutic interventional or surgical procedure performed within 30
days prior to the index procedure (e.g., stent placement).

- Any planned therapeutic interventional or surgical procedure planned within 30 days
following the index procedure

- Open chest surgery contraindication (e.g., acute respiratory distress, endocarditis,
myocarditis).

- Structural abnormality of the mitral valve

- Valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or
tricuspid valve requiring intervention.

- Pericardial effusion >5 mm via echocardiography.

- Posterior wall end-diastolic dimension >1.3 cm.

- Left ventricular end diastolic diameter > 7.0 cm.