Flat Medical announced FDA 510(k) clearance of EpiFaith®, the Epidural Safety Solution
Flat Medical Co., Ltd., the medtech company specializing in clinical safety solutions, announced it received 510(k) clearance from the U.S. Food and Drug Administration for its EpiFaith® syringe to deliver safe epidural locating solution.
Based on the LOR technique, the EpiFaith® syringe is a physician-centered safeguard for epidural analgesia, which is indicated for painless labor, surgical anesthesia and chronic pain management. Compared with traditional practice that relies on the manual sense, EpiFaith® provides intuitive signal that tells anesthesiologists the arrival of epidural space, thus prevent the accidental puncture to dura, avoiding the risk of serious headache, paralysis, prolonged admission time, and related healthcare costs.
“Post-dural puncture headache is a complication which unfortunately occurs in 1-2% of epidural procedures, when the needle is inadvertently advanced through the dura.” said Dr. Edward T. Riley, MD, Professor of Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University Hospital. “EpiFaith is a novel device which has the potential to reduce this debilitating complication by providing a clear and objective indication for when the epidural space is encountered. EpiFaith may help both novice and expert proceduralists and reduce the suffering of thousands of patients.”
Previous to the FDA clearance, EpiFaith® has been CE certified since last October. By receiving FDA clearance this time, the Company says the official global launch of the EpiFaith® syringe will be in May, 2019. “It’s an exciting news that we have taken a step to the safer and intuitive puncture scenario. Now we have the opportunity to deliver safe epidural locating to millions of patients in the U.S.” said Dr. Joseph Luo, Chairman and CEO of Flat Medical. “EpiFaith for epidural is just the start of our clinical safeguard pipeline, we will continuously ease the clinical risks through innovation on the risky procedures.” Flat Medical will exhibit at the upcoming SOAP annual meeting, OAA annual meeting and Euroanaesthesia 2019.
About Flat Medical
Flat Medical is a medtech company focusing on developing safety solutions for clinical procedures. Supported by key opinions leaders and valuable venture capitalists in the United States, Europe and Asia, the company is now commercializing their first product, EpiFaith®, the physician-centered safeguard for epidural, to the market. Other applications of the EpiFaith® tech are under development and are expected to be launched in 2020.
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