Saeum Meditec, a South Korean company, will showcase an innovative medical pressure monitor, EPI-Detection, at the upcoming AAOS 2019 (American Academy of Orthopedic surgeons) annual meeting in Las Vegas during the 13-15 March.
EPI-Detection is a medical pressure monitoring device to detect the epidural space in epidural anesthesia.
As cervical epidural anesthesia is most difficult procedure with more complications than Lumber or thoracic approach, reaching the epidural space in safety and accuracy has been one of the top concerns of anesthesiologists.
For epidural anesthesia, most commonly used methods is Loss of Resistance technique using saline (LOR) and it depends on the anesthesiologist’s or surgeon’s skill level in placing ESI (Epidural Steroid Injection). Furthermore, it is very difficult in patients who are obese or have abnormal vertebral anatomy.
To solve significant unmet needs, the EPI-Detection was invented to detect the epidural space for more accurate procedure. When the epidural needle reaches the epidural space, it detects the pressure change of the muscle layer and epidural space. The pressure sensor recognizes this, which is displayed on an LED so that the user can easily identify it.
It has a structural feature (Luer-lock) that allows the Racz’s catheter to be inserted right away. To put it simply, the device supports the safe treatment of patients by allowing the epidural needle to precisely reach the epidural space.
In Korea, the total number of Epidural procedures is estimated to be about 32 million by 2017. Number of case of Epidural nerve block – One-time block (cervical and thoracic) (CPT in Korea: LA321) is 452,302 and Number of case of Epidural nerve block – One-time block (lumbar and sacrum) (CPT in Korea: LA322) is 2,674,754. Number of case of Labor epidural for vaginal delivery is 196,451.
There are now about 9 million epidural steroid injections performed annually in the U.S and the number of procedures appears to be growing.
Market has a big potential as well as an aging population is growing over the world.
Clinical trials of the device are currently underway. Efficiency and stability have been verified since 2016 and the current study, which initiated in January 2018, uses Epi Detection in 70 cases to verify how the procedure time is shortened into 43% and how many times the use of C-Arm and radioactivity is reduced into 52%. Results are expected to be announced early this year.
The innovation was launched at MEDICA 2018 to its international audience. As well as at Association of Anesthetists UK – Winter Scientific Meeting 2019 (14th Jan), it has received enthusiastic responses. After the events, the made-in-Korea device is being exported to UK, Denmark, Spain, Turkey and Kuwait. Saeum Meditec is currently on discussion with their partners in EU including Germany and Italy to broaden its market.
“After the successful launching of EPI-Detection in global market at last MEDICA 2018, we are delighted to present the device to undiscovered customers,” said Sang-Won Yoon, CEO, of Saeum Meditec. “We will continue catching the eyes of customers around the globe through the American Academy of Orthopedic surgeons. Currently we are preparing the documents for 510(k) and will submit them soon after internal review,” he added.
For more information : www.saeummeditec.com
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