Collect patient data and to monitor the clinical use (safety and efficacy) of the device

Inclusion criteria:

- Patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure

Exclusion criteria

The device is contraindicated for patients known to have any of the following:

• Known coagulation dysfunction
• Leak reversal with separate or significant residual or recurrent leak
• Acute infection
• Known intra-cardiac thrombi
• Recent pelvic venous thrombosis
• Recent myocardial infarction or a surgical bypass operation in the last 30 days
• If adequate oral anticoagulation therapy / antiplatelet aggregation inhibition is not possible post-procedurally
• Intolerance of contrast agent

Patients with aortic or mitral PVL