A research team at a university hospital in Korea is drawing keen attention as it demonstrated excellent performance by reducing the amount of radiation exposure and procedure times using the EPI-Detection®, a digital medical pressure checker from Saeum Meditec, compared to traditional Loss of Resistance (LOR) technique.
Epi-Detection® is expected to play a role in helping to secure procedures as the physician finds out that the needle for epidural infusion has safely reached the epidural space during epidural nerve block or neuroplasties.
Last month, a team of neurosurgeons at Yonsei University hospital published a paper titled “Study on the Clinical Usability of Detecting Epidural Space Using a Medical Pressure Checker by Surgery in the Procedure of Epidural Nerve Block, Neuroplasty.”
Traditionally, the most commonly used method of finding epidural space in a cervical vertebra is Loss of Resistance (LOR). However, it takes a long time to master the technique and can be somewhat dangerous for first-time or inexperienced practitioners. In the case of patients with yellow ligament deformities, the patient cannot confirm exactly.
To minimize these problems, a medical pressure checker (EPI-Detection®) that accurately detects epidural space was developed. EPI-Detection measures the difference in pressure between the muscle layer and the epidural space, and when the needle for epidural infusion needle reaches the epidural space, the pressure sensor detects it and signals it using LED lights.
The Yonsei University team evaluated the clinical significance of the two procedures, including procedure time, exposure from C-Arm’s radiation, and complications (safety) by comparing LOR with the EPI-Detection device.
For patients, shorter treatment time is a helpful part of reducing the risk of infection and psychological stability. Similarly, it also reduces the burden of the procedure by reducing the time it takes to find the correct location.
Total C-arm usage time was 11.39±6.48 seconds in the LOR implementation group and 7.49±3.44 seconds in the EPI-Detection implementation group, with a statistically significant difference (p=0.007). The radiation dose was also statistically different (0.038±0.034mGym2, LOR vs 0.022±0.020mGym2, EPC, p=0.040).
The research team said that cervical epidural neuroplasty procedures using the new epidural pressure checker were safer and more effective than LOR procedures due to shorter procedure time, lower radiation irradiation, and reduced radiation exposure.
In addition, the research team decided that for the lumbar spine, which has lower treatment difficulty compared to cervical vertebrae, the EPI-Detection could be better applied for epidural nerve block and neuroplasties..
“Currently we are preparing the documents for FDA approval. We are doing our best with the goal of entering the U.S.” said Sang-Won Yun, CEO, of Saeum Meditec. “We will continue catching the eyes of customers around the globe through the American Society of Anesthesiologists (ASA),” he added.
For more information: www.saeummeditec.com
Related: EPI-DETECTION, an Innovative Automatic Pressure Monitor for Epidural Injections; Saeum Meditec to Showcase EPI-Detection, an Innovative Pressure Monitor, at AAOS 2019