Completion of Patient Enrollment in Largest Multicenter Randomized Controlled Trial of High Frequency Spinal Cord Stimulation for Painful Diabetic Neuropathy

OrthoNext Digital Platform for the JuniOrtho Plating System Receives FDA Clearance

“Together, OrthoNext and the JuniOrtho Plating System provide a complete solution for surgeons looking for a plating system to address the specific demands of advanced deformity and trauma reconstruction of the lower extremities in the pediatric population,” said Orthofix President of Global Orthopedics Paul Gonsalves.

SonarMed, New Pediatric Monitor Alerts Clinicians To Potential Airway Obstructions During Ventilation Launched

"The SonarMed airway monitoring device has revolutionized the way we care for our littlest patients. There is no other device in the world that can tell you where the endotracheal tube is located within the airway continuously in real-time, and whether the tube is obstructed or even partially occluded," said Jamie W. Powers, M.D., MBA, neonatologist at Huntington Hospital in Pasadena, California.

Nevro Corp. (NYSE: NVRO), a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain conditions, today announced that it has completed patient enrollment in its prospective, multicenter Randomized 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 ten adults in the United States and can damage peripheral nerves, resulting in severe pain and numbness in the hands and feet.  According to published literature, there are approximately 4 million diabetic patients suffering from painful diabetic neuropathy in the U.S. alone.

The SENZA-PDN study compares HF10 therapy plus Conventional Medical Management (CMM) to CMM alone in 216 patients at 18 centers in the United States. The primary endpoint of the study is the difference in proportion of treatment responders at 3-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.  We thank Dr. Erika Petersen, Director of Functional and Restorative Neurosurgery at UAMS, for serving as the lead Principal Investigator for this study.”

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