It’s not for an orthopedic medical device, but Medtronic, Inc. has received landmark FDA approval under new draft guidance to conduct an early feasibility study.
The approval to study Medtronic’s Native Outflow Tract Transcatheder Pulmonary Valve (TPV), represent the first-ever FDA approval of an investigational device exemption (IDE).
Investigational Device Exemption
The intent of the FDA`s draft guidance, “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies, ” is to foster early-stage development of medical devices within the U.S. 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 sponsors (manufacturers) and FDA device reviewers more flexibility to make device modifications once the study begins.
The FDA hopes that early feasibility studies allow for early clinical evaluation of devices to provide proof of principle and initial clinical safety data. These studies may be appropriate early in device development when clinical experience is necessary because nonclinical testing methods are not available or adequate to provide the information needed to advance the developmental process.
The agency says it recognizes the value of encouraging medical device innovation to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable, ineffective, or associated with substantial risks to patient safety. This guidance has been developed to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects in early feasibility studies.
Qualifications
To improve the likelihood of IDE approval, the following questions should be addressed by the sponsor, with supporting materials, in the original early feasibility study IDE application:
- What is the clinical condition to be treated or assessed by the device?
- What is the standard of care for the clinical condition and expected clinical outcomes associated with the standard of care?
- Does the information included in the Report of Prior Investigations (Section 5) support initiation of the study?
- Does the Investigational Plan include a thorough risk/benefit analysis, sufficient risk mitigation strategies, adequate human subject protection measures, and an appropriate clinical study protocol (see Section 6)?
- Is initiation of the clinical study justified based on the responses to the aforementioned questions?
“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 (small tube) funneled through the veins, the valve is designed to restore pulmonary valve competency without invasive open-heart surgery.
To learn if your device qualifies, click here.
