EPI-DETECTION, an Innovative Automatic Pressure Monitor for Epidural Injections

Saeum Meditec, a Korean firm, recently acquired European CE Mark approval for its EPI-DETECTION device, a novel digital pressure monitor with original technology developed by the company with help from Severance Hospital, Yonsei University.

“In the field of medical devices, we were able to create something new from an existing concept based on our R&D oriented identity and we devote ourselves to product development with the intention of switching ideas,” said Sangwon Yoon, CEO of Saeum. “Our mission is, ‘We strive to deliver practical medical devices by IT convergence engineering for safer and more effective procedures to improve healthcare outcomes for all.’”

Applications (Anesthesia & OB/GYN):

• Epidural Steroid Injections (cervical, lumbar, thoracic epidural)
• Labor Epidural for Cesarean Section

The utilization of health care services for chronic low back pain has increased substantially over the past two decades. (Source: Freburger, Janet K. et al. “The Rising Prevalence of Chronic Low Back Pain.” Archives of Internal Medicine 169.3 (2009): 251–258. PMC. Web. 17 Aug. 2018.)

Overall epidural injections increased 99% per 100,000 Medicare beneficiaries (2000-2014) and 2.25 million in 2014 (45%). (Source : Laxmaiah Manchikanti et al. BMJ Open 2016;6:e013042)

For treatment of back pain, 95% of people look for interventional management. Depending on the type of back pain you have, your doctor might recommend medications. Over-the-counter (OTC) pain relievers maybe some of them. If other measures don’t relieve your pain, and if your pain radiates down your leg, your doctor may inject cortisone, an anti-inflammatory medication, or numbing medication, into the space around your spinal cord (epidural space). A cortisone injection helps decrease inflammation around the nerve roots, but the pain relief usually lasts less than a few months.

• For epidural injection, 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-Detectio was invented to detect the epidural space for accuracy of ESI. 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 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 procedures for neuroprotection is estimated to be about 25 million by 2017. Epidural block is 20% and Caudal block is 30%. Neuroplasty is performed about 150,000 every year.
• 

EPI Detection, created with the advice of Severance Hospital medical staff, helps to perform ESI quickly and accurately. The disadvantage of the resistance dissipation method, which has been widely used in the past, has been revolutionized, and the digital sensor recognizes the pressure change and informs the exact location of the epidural space.

The pressure changes in the body-specific area are measured with a digital sensor and displayed by the LED as green (ready) and blue (detection) so that the operator can identify the puncture needle to reach the exact position of the epidural space.

Yoon Sangwon, CEO of Saeum Meditec, said, “Koreans use chopsticks everyday at the kitchen table. Their finger culture may be superior to people in many foreign countries. Because the traditional method is very dependent on the sense of the practitioner (tactile feedback at the finger tips), it is of great help to young doctors all 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 and how many times the use of C-Arm and radioactivity is reduced. Results are expected to be announced soon.

“We plan to show off our technology by participating in MEDICA in Dusseldorf, Germany (booth location : Hall 7a / C09 ) “We will also expand our product line-up gradually in the future by 2022,” he added.

“We are an R & D based company. I will continue to do my best in the process of researching the technology that medical practitioners actually need and making this idea into a medical device. ”

Here’s a video introducing the EPI-Detection device:

Source: www.medgadget.com