Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Dev...
Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States
- Health burden of heart failure in the US is a call to action to optimize device regulatory practices.
- Innovative methodologies are needed for device clinical evaluation.
- Experts must actively partner with the FDA in all aspects of mechanical circulatory support development.
Read the full article in Circulation: Heart Failure
Circulation: Heart Failure. 2013: published online before print November 12, 2012, 10.1161/HHF.0b013e318279f55d.
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