Checkpoint BEST

Checkpoint Surgical has received FDA Breakthrough Device Designation for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST system is, a press release reports, 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.

President and CEO of Checkpoint Surgical Len Cosentino comments: “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. Based on the recently published research by our clinical partners, Susan Mackinnon and 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.”

Amy Moore (Washington School of Medicine, St Louis, USA) says: “The Checkpoint BEST technology represents a paradigm shift in the treatment algorithm of nerve injuries, if proven successful in our clinical trial. As clinicians we will be able to proactively deliver a therapeutic intervention which augments the current care and counters the inefficient initiation of nerve regrowth. I look forward to continuing my collaboration with Checkpoint Surgical to develop both the science and technology of the Checkpoint BEST system.”

The FDA’s Breakthrough Devices programme is intended to give patients and health care providers more timely access to breakthrough technologies that have the potential to provide more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Checkpoint Surgical with priority review and interactive engagement regarding device development.