Checkpoint Surgical issued the following announcement on Sep. 11.
Checkpoint Surgical, Inc., 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.”
“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,” said 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.
About Checkpoint Surgical, Inc.
Checkpoint Surgical (Cleveland, Ohio) is a privately held medical device company committed to providing surgeons with user-friendly, cost-effective devices to protect and repair nerves intraoperatively across the anatomy. Our mission is to advance the science and practice of nerve protection and repair to improve the quality of life for patients and physicians. Our technologies are state of the art for hand-held motor nerve location, identification and assessment in peripheral nerve repair surgery, targeted muscle reinnervation, upper and lower extremity orthopedic surgery, and head and neck surgical oncology. For more information regarding Checkpoint Surgical please visit www.checkpointsurgical.com.
About Checkpoint Surgical Products
Checkpoint Surgical’s flagship product, the Checkpoint® Stimulator/Locator is a state-of-the-art hand- held, single-use, intraoperative nerve and muscle stimulator that helps surgeons locate, identify and evaluate motor nerve tissue and muscle function in complex surgical procedures that require careful tissue dissection or nerve exploration and repair. The Checkpoint® Head & Neck is a hand-held, single use, intraoperative nerve stimulator designed specifically for head and neck procedures to help surgeons locate, identify and evaluate motor nerve tissue and muscle function in surgical procedures that require reliable nerve assessment, protection and repair.
Original source can be found here.
