Flat Medical Announces CE Approval for EpiFaith® Syringe for localization of the Epidural Space
Flat Medical, a startup company based in Taiwan focused on the safety issue of blind puncture of clinical practice. Today, Flat Medical announced it has received CE Mark approval for EpiFaith® syringe, the epidural locating syringe with faith signal.
Locating the epidural space is an indispensable part of obstetrical analgesia, surgical anesthesia, postoperative analgesia, and chronic pain control. However, using the LOR hand feeling to locate epidural space relies on manual skill of the operator and the considerable experiences. Hence, the current incidence rates of accidental dural punctures are 0.19-3.6%.
"This regulatory approval is an important milestone for Flat Medical, which will allow us to bring the safety guard of epidural localization," said Joseph Luo, CEO of the Flat Medical. " It is beneficial to both junior and senior physicians by transforming the process into a safe and convenient procedure."
Flat Medical plans to launch EpiFaith syringe over the next 3-6 months in select academic medical centers to build strong clinical experiences, followed by a full commercial launch. The Company will also participate the ASA, SOAP, ESA to promote the EpiFaith syringe.
About the EpiFaith® syringe
The EpiFaith® syringe is an improved LOR device with the ability to warn and help physicians to achieve the safe insertion is required. EpiFaith syringe provides objective, and quantitative pressure information as well as a visual signal which is triggered at the moment the needle tip enters the epidural space. Hence, the anesthesiologist can get a clear endpoint for the advancing of the needle easily. The advantages of EpiFaith syringe including that the anesthesiologist can control the epidural needle with both hands and achieve the real- time pressure detection.