ENPATH DEVICE APPEAL REJECTED BY FDA
Medical devicemaker Enpath Medical said the Office of Device Evaluation (ODE) at the FDA denied the company's appeal of the decision by the ODE staff that the pending premarket application of its Myopore Rx steroid lead is not approvable as currently submitted.
The FDA rejected Enpath's application for the Myopore Rx steroid lead in December, saying it would not approve the product without human trials. Enpath said at that time that it had understood from the agency that the device -- a thin wire that connects a pacemaker to a patient's heart -- could be cleared on more limited data.
"It is not feasible for us to undertake human clinical trials at this late date in the development process, due to the substantial cost and time required," Chairman and Chief Executive Jim Hartman said. "We are meeting with our distribution partners to evaluate possible strategies moving forward and also exploring other options with the FDA, although limited, which might gain marketing clearance of this product."