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The aVAD™
HeartAssist5®
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CAUTION Investigational Device. The HeartAssist5® is a device limited by Federal law to investigational use in the United States.
The aVAD™ is currently under regulatory review and not approved for investigational or commercial use in the United States.
The VAD Maintenance System is currently under regulatory review and not approved for investigational or commercial use in the United States.
The aVAD™ and HeartAssist5® have received CE Mark approval for distribution in Europe.
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