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Medtronic Transcatheter Pulmonary Valve Study Begins Under Draft FDA Feasibility Study Guidance

In granting IDE approval for a feasibility study of Medtronic’s Native Outflow Tract Transcatheter Pulmonary Valve, FDA followed a pathway laid out in a November 2011 draft guidance intended to streamline requirements for starting up and modifying early feasibility studies.

Medtronic is the first to gain an investigational device exemption approval from FDA under a new set of agency policies intended to accelerate the process for starting up early-stage feasibility studies.

The firm announced IDE approval for a feasibility study of its Native Outflow Tract Transcatheter Pulmonary Valve Feb. 26. In granting the approval, FDA followed a pathway laid out in a November 2011 draft guidance intended to streamline requirements for starting up and modifying early feasibility studies

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