Nevro this week announced it enrolled the first patient in its painful diabetic neuropathy (PDN) sensory study.
The prospective randomized controlled trial will assess the restoration of neurological function as a primary objective in patients with intractable PDN. It will enroll up to 236 patients at multiple sites across the U.S.
Patients in the trial will be randomized to conventional medical management or 10 kHz Therapy, along with conventional medical management with optional crossover to the other treatment arm at 6 months if the criteria are met.
The FDA previously granted breakthrough device designation for the study and the potential device indication. The FDA’s designation enables Nevro to receive a quicker review for its marketing application, which seeks to broaden its FDA labeling. This will give patients and healthcare providers faster access to vital medical devices that can provide improved treatment or diagnosis of serious, irrever…