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Medtronic gains FDA approval to conduct early feasibility medical device study
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Medtronic announced that it has received FDA approval to conduct an early feasibility study using the Medtronic Native Outflow Tract Transcatheter Pulmonary Valve, according to a press release.
This approval represents the first FDA approval of an investigational device exemption (IDE) following the new FDA draft guidance for early feasibility studies, according to the company-issued release.
The minimally invasive Native Outflow Tract Transcatheter Pulmonary Valve is indicated for patients with congenital heart disease who do not have a right ventricle-to-pulmonary artery conduit. The valve is designed to restore pulmonary valve competency.
The new FDA draft guidance is intended to allow studies to start earlier in the device development process than previously allowed, while providing appropriate human subject protections. It also permits sponsors, or manufacturers, and FDA device reviewers more flexibility to make device modifications once the study begins, according to the release.
According to the company, this early feasibility study will evaluate the design, procedural success and initial performance of the Native Outflow Tract Transcatheter Pulmonary Valve to enable further development of the device prior to conducting an additional clinical study.