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Freedom SOLO Stentless Heart Valve · 1 trial · 2 indications
The complication and survival rates for the SOLO valve are comparable to appropriate historical controls manifested as objective performance criteria (OPCs) and to that reported in the literature for other stentless bioprostheses and stented pericardial valves.
| Arm | Type | Description |
|---|---|---|
| Freedom SOLO stentless valve implant | EXPERIMENTAL | Appropriate subjects will receive the Freedom SOLO stentless valve implant as a replacement for a diseased or damaged native or prosthetic aortic valve. |
| Name | Type | Description |
|---|---|---|
| Freedom SOLO Stentless Heart Valve | DEVICE | Freedom SOLO Stentless Heart Valve |
Inclusion Criteria: * The subject is male or female 18 years old or older. * The subject or subject's legal representative is willing to sign the informed consent. * The subject which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement. * Any subject amenabl...