Medtronic has announced that it has received FDA approval to conduct an early feasibility study of its native outflow tract transcatheter pulmonary valve. 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, 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 transcatheter pulmonary valve is a minimally invasive therapy for patients with congenital heart disease who do not 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) funnelled through the veins, the valve 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 device to enable further development prior to conducting an additional clinical study.