FDA’s Early Feasibility Medical Devices Clinical Studies program, meant to speed up the regulatory review process of innovative medical devices, has spawned its first graduate.
Medtronic announced Tuesday that it has received the first FDA approval to conduct an early feasibility study of its Native Outflow Tract Transcatheter Pulmonary Valve. It is a minimally invasive device aimed at people with congenital heart disease who don’t have the requisite conduit to maintain proper blood flow between the right ventricle and the pulmonary artery.
“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 a news release. “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The Early Feasibility Medical Devices Clinical Studies program has its roots in a 2011 draft guidance at a time when the FDA and Jeffrey Shuren was looking for ways to change an image of an agency that industry has long complained of being slow to understand innovation and approve new products. ()
Medtronic has another device aimed at treating aortic aneurysms in the FDA program. That device is part of the company’s Endovascular Therapies business, explained Tracy McNulty, a Medtronic spokeswoman.
On Tuesday, an FDA spokeswoman could not immediately respond to a query about what other devices are part of this program. Previously, when Medtronic announced that its aortic aneurysm device was part of the pilot program, along with eight other devices, the agency cited confidentiality agreements as a reason for not identifying those companies and their products.
—Arundhati Parmar, Senior Editor, MD+DI