The Checkpoint brief electrostimulation therapy (BEST) system from Checkpoint Surgical Inc has received Breakthrough Device designation from the US Food and Drug Administration (FDA).
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, according to a media release from Checkpoint Medical.
“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,” says 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.”
“Based on our recent animal study, I am excited to be involved in multi-center clinical trials evaluating the potential for a short period of electrical stimulation to enhance nerve regeneration and improve function,” states Dr Susan Mackinnon, Shoenberg Professor, Plastic and Reconstructive Surgery, Chief, Division of Plastic and Reconstructive Surgery, Washington University School of Medicine.
“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,” said Amy Moore, MD, Associate Professor of Surgery, Chief, Section of Hand Surgery, Program Director – Hand Fellowship, Plastic and Reconstructive Surgery, Washington University School of Medicine.
“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 Program 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.
[Source(s): Checkpoint Medical Inc, Business Wire]