Nevro has announced that it has completed patient enrolment in its prospective, multicentre randomised controlled trial (RCT) for the treatment of chronic pain for patients who suffer from painful diabetic neuropathy (PDN).
“This is an important step in the evaluation of Nevro’s Senza HF10 therapy for this very large and often undertreated patient population,” said D Keith Grossman, Nevro’s chairman, CEO and president. “Diabetes affects nearly one in 10 adults in the USA and can damage peripheral nerves, resulting in severe pain and numbness in the hands and feet. According to published literature, there are approximately four million diabetic patients suffering from painful diabetic neuropathy in the USA alone. The SENZA-PDN study compares HF10 therapy plus conventional medical management (CMM) to CMM alone in 216 patients at 18 centres in the USA.
“The primary endpoint of the study is the difference in proportion of treatment responders at three-month follow-up and the study will collect outcomes out to 24 months. This RCT is designed to provide safety and efficacy data, which will be used to support customer adoption and efforts to ensure adequate payor coverage of this procedure.”