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

This article was originally published in The Gray Sheet

Executive Summary

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of Medtronic’s Native Outflow Tract Transcatheter Pulmonary Valve, FDA followed a pathway laid out in a November 2011 draft guidance intended to streamline requirements for starting up and modifying early feasibility studies.

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CardiAQ Uses Early-Feasibility IDE Paradigm To Bring Trans-Mitral Valve Device To U.S. Clinicians

The California startup was able to leverage a new FDA process for early-feasibility device trials to launch a small U.S. study of its transfemoral and transapical transcatheter mitral valve implantation systems.

CDRH Sequestration Impact: Training, Standards And Reg Science

CDRH Director Jeffrey Shuren detailed last week how federal sequestration cuts to FDA are impacting specific device center programs, including training, standards development and regulatory science. Shuren also signaled imminent policy releases from the center, including a finalized post-market surveillance plan.

Regulatory News In Brief

FDA issues safety notice on Covidien catheter. Medtronic stent graft selected for FDA’s early feasibility pilot program. More regulatory news.

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