Checkpoint Surgical, a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST™ system is designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury, with the goal of accelerating and improving patient recovery.
“We are pleased to receive the Breakthrough Device designation from the FDA as it will allow Checkpoint Surgical to deliver this important innovation in nerve regeneration for patients much sooner,” said President and CEO Len Cosentino. “Based on the recently published research by our clinical partners Dr. Susan Mackinnon and Dr. Amy Moore at Washington University in St. Louis, we believe the Checkpoint BEST system will be transformational for the treatment of nerve injuries. We are actively enrolling patients in a clinical study of the Checkpoint BEST technology at Washington University in St. Louis and working to add additional surgeon collaborators and study sites.”