Medtronic's ($MDT) Valiant Mona LSA is one of 9 early-stage devices picked by the FDA for a pilot program to gather clinical safety data on novel techs. The stent graft is designed to repair thoracic aortic aneurysms in arteries.
The FDA launched its Early Feasibility Medical Device Clinical Study program in November, enrolling devices not yet ready for broad trials, but with enough of a safety profile for small-scale studies, MedCity News reports. The FDA hasn't disclosed the other devices involved in the program, and the trials will likely not exceed 10 patients each.
Medtronic, for its part, is confident the early studies will help progress the Valiant tech toward an eventual FDA application, and its selection for the pilot program demonstrates the FDA's understanding of the need for innovation in the stent world, said Medtronic's Endovascular Therapies Vice President and General Manager, Tony Semedo, in a statement. "Our Valiant Mona LSA system could potentially obviate the need for LSA bypass procedures, extending the benefits of endovascular repair without surgery to more patients with thoracic aortic aneurysms."
Valiant and the other pilot devices are in their very early stages, without finalized designs in some cases, according to the FDA. The early feasibility program is aimed to help devicemakers hone their techs to increase the odds of later approval.
- read Medtronic's release
- here's the FDA's guidance on the program
- get more from MedCity News