Medtronic (NYSE:MDT) said the FDA approved an early trial of its native outflow tract transcatheter pulmonary valve under a new agency program for early feasibility studies.
The TPV device is designed for patients born without a right ventricle-to-pulmonary artery conduit, which provides blood to the lungs, as an alternative to open heart surgery.
Medtronic, Inc. (NYSE: MDT) today announced that it has received U.S. Food and Drug Administration (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.
The FDA issued draft guidance for investigational device exemptions to encourage the development of early-stage devices by incorporating clinical work much earlier in the product cycle. The aim is also to allow medical device companies to adapt the devices on the fly, with appropriate agency oversight.
"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," Dr. John Liddicoat, president of Medtronic’s structural heart business, said in prepared remarks. "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 Medtronic 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," according to a press release.
