February 26, 2013 — Medtronic Inc. announced it received U.S. Food and Drug Administration (FDA) approval to conduct an early feasibility study using its self-expanding Native Outflow Tract Transcatheter Pulmonary Valve (TPV). This approval represents the first-ever FDA approval of an investigational device exemption (IDE) following the new draft FDA guidance for early feasibility studies.
“The approval of this study is an excellent example of how the FDA and manufacturers can work together to advance medical innovation by studying initial device design and functionality, with the long-term goal of delivering novel therapies to patients in need,” said John Liddicoat, M.D., senior vice president of Medtronic and president of the Medtronic structural heart business. “In this case, the early feasibility study will help us develop a minimally invasive therapy for patients whose only current treatment option is open-heart surgery.”
The Native Outflow Tract TPV is a minimally invasive therapy for patients with congenital heart disease who don’t have a right ventricle-to-pulmonary artery conduit, and need a pulmonary valve to maintain adequate blood flow from the right ventricle and the pulmonary artery. Delivered in a minimally invasive procedure using a catheter funneled through the veins, the valve is designed to restore pulmonary valve competency without invasive open-heart surgery.
The intent of the FDA’s draft guidance for investigational device exemptions for early feasibility medical device clinical studies, including first in human (FIH) studies, is to foster early-stage development of medical devices within the United States. It is a new approach to clinical studies conducted in the early stages of development, and is designed to facilitate early clinical experience with investigational medical devices to reach patients sooner and create incentives to innovate in the United States.
This new approach is intended to allow studies to start earlier in the device development process than previously allowed, while still providing appropriate human subject protections. It also permits manufacturers and FDA device reviewers more flexibility to make device modifications once the study begins.
The Medtronic early feasibility study will evaluate the design, procedural success and initial performance of the Native Outflow Tract TPV to enable further development of the device prior to conducting an additional clinical study.
Medtronic already has several years experience with transcatheter pulmonary valves with its Melody valve. It was cleared for limited use by the FDA under a humanitarian device exemption for use in fewer than 1,000 patients a year. It has been primarily used in pediatric patients.
For more information: www.medtronic.com