The US Food and Drug Administration (FDA) has granted approval to Medtronic to conduct an early feasibility study on its Native Outflow Tract transcatheter pulmonary valve (TPV) to treat patients with pulmonary valve failure.
The investigational device exemption (IDE) study approval was based on the new draft FDA guidance for early feasibility studies.
Medtronic senior vice president and Medtronic structural heart business president Dr John Liddicoat said the approval represents that how the FDA and manufacturers work together to advance medical innovation by studying initial device design and functionality, with the long-term goal of delivering new therapies to patients in need.
"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," Liddicoat said.
The minimally invasive therapy is designed for use in 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.
Using a catheter (small tube) funnelled through the veins, the valve is delivered in a minimally invasive procedure to restore pulmonary valve competency without invasive open-heart surgery.
The 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.
The new study approach also permits manufacturers and FDA device reviewers more flexibility to make device modifications once the study begins, according to Medtronic.
Image: Medtronic corporate headquarters in Fridley, Minnesota, US. Photo: Courtesy of Bobak Ha’Eri.