FDA Gives the Go-Ahead on Pulmonary Valve Trial

Published date : 27 February 2013
Article date : 27 February 2013


Mass Device covers the FDA's go-ahead on an early feasibility trial of Medtronic's Native Outflow Tract Transcatheter Pulmonary Valve (TPV). The early trial of the device will run under a new agency program for early feasibility studies. The device is designed for patients born without a right ventricle-to-pulmonary artery conduit, as an alternative to open heart surgery. 

The FDA approval represents the first of its kind for the investigational device exemption following the new draft FDA guidance for early feasibility studies. The FDA issued draft guidance for IDE to encourage the development of early stage devices by incorporating clinical work much earlier in the product cycle. The aim is also to allow medical device companies to adapt the devices with appropriate agency oversight. 

According to a press release from Medtronic, the study "will evaluate the design, procedural success and initial performance of the native outflow tract TPV to allow further development of the devicebefore conducting an additional clinical study."

Source: Brad Perriello, Mass Device, 26 February 2013

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