Flat Medical Co., Ltd., Receives 510(k) clearance from the FDA for its EpiFaith® Syringe

Sunday, February 23, 2020

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.

“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.”

Based on the LOR technique, the EpiFaith® syringe is a physician-centered safeguard for epidural analgesia, 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.

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 the start of our clinical safeguard pipeline, we will continuously ease the clinical risks through innovation on risky procedures.” Flat Medical just had an extremely successful exhibition at SOAP annual meeting, and will attend the OAA annual meeting and Euroanaesthesia 2019 in Newcastle and Vienna.

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