Medtronic Gains First FDA Approval Under New Early Feasibility Study Rules

In short

Medtronic, Inc. has received U.S. FDA approval to conduct an early feasibility study using the Medtronic 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.

Background

This is an interesting landmark because it represents the first time a company has gained approval to commence a study under the FDA’s new (and still draft) guidance. The so-called “Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, including First in Human (FIH) Studies,” is designed to keep and encourage early stage device development to stay in the United States. In theory this should encourage innovation while still ensuring the patient is appropriately protected.

So what’s the therapy? Well, TPV insertion is a minimally invasive therapy for patients with congenital heart disease who don’t have a patent right ventricle-to-pulmonary artery conduit, and need a pulmonary valve to maintain adequate blood flow from the right ventricle and through the pulmonary artery. In essence the valve, inserted “trans-catheter”, is designed to restore pulmonary valve competency without invasive open-heart surgery.

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.

Company comments

“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.”

Source: Medtronic, Inc.