Caisson Transcatheter Mitral Valve Replacement (TMVR) System Early Feasibility Study

The treatment guidelines for valvular heart disease indicate that surgical correction of
primary mitral valve regurgitation (MR) is a Class I recommendation. Further, 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. Currently, the only approved percutaneous
treatment for MR is MitraClip. MitraClip is limited to a specific population of high risk
surgical patients with valvular prolapses that are amenable to repair by the edge to edge
technique. The feasibility of percutaneous MV replacement has been shown in animal studies,
the implantation of aortic valves at the mitral position, and early evaluations of purpose
made transcatheter MVs in humans. 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 initial 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; transischemic attack or myocardial infarction within 30 days of
the index procedure