The device is a minimally invasive therapy 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.
The valve, which uses a catheter (small tube) funnelled through the veins, is delivered in a minimally invasive procedure to restore pulmonary valve competency without invasive open-heart surgery, according to the company.
The investigational device exemption (IDE) study approval was based on the new draft FDA guidance for early feasibility studies.
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.
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.
