Caisson Transcatheter Mitral Valve Replacement (TMVR)

The treatment guidelines for valvular heart disease indicate that surgical correction of
primary mitral valve regurgitation (MR) is a Class I recommendation. Recent evidence
indicates that valve replacement is at least as effective as repair in both primary and
secondary MR patients. However, many patients are not referred for surgery as they are
considered to be too high of a risk to undergo on-pump, open-heart procedures. Percutaneous
aortic valve replacement has made treatment of stenosed aortic valves available to high-risk
surgical patients who would have otherwise been medically managed. Percutaneous mitral valve
(MV) replacement offers similar advantages. The feasibility of percutaneous MV replacement
has been demonstrated in early feasibility studies. To meet this medical need, Caisson
Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve.
As with patients with aortic valve (AV) deficiencies, this device can be used to provide
needed therapy to patients who might not otherwise receive treatment beyond medical therapy.
This study will provide information on the safety and performance of this system.

Inclusion Criteria:

- Has severe mitral regurgitation

- New York Heart Association (NYHA) Class II, III, IVa or heart failure

- High risk for cardiovascular surgery

Exclusion Criteria:

- Excessive calcification or thickening of mitral valve annulus

- Severe mitral stenosis, fused commissures, valvular vegetation or mass

- Left ventricular end diastolic dimension > 7cm

- Left ventricular outflow tract obstruction

- Severe right ventricular dysfunction

- Stroke within 90 days; transient ischemic attack or myocardial infarction within 30
days of the index procedure