L&K Biomed has received the U.S. Food and Drug Administration’s approval Wednesday for its sacroiliac (SI) joint fusion system that applies the minimally invasive surgical (MIS) technique for the sacroiliac joint.
Sacroiliac joint dysfunction, also called SI, joint pain, is caused by dysfunction in the SI joint that can cause lower back or leg pain. About 15 to 30 percent of lower back pain is attributable to the SI joint.
L&K Biomed, which specializes in spinal implants, said that the product is the world’s first to apply the minimally invasive surgical technique to the sacroiliac joint as well as serving as the first such Korean product to be approved by the FDA.
The MIS technique has become increasingly preferred to the traditional method of incising the surgical site during the operation. The surgical approach has the advantage of minimizing the incision during surgery and the loss of muscle in addition to reducing the amount of bleeding, shortening operation time, and reducing the risk of infection.
L&K Bio said it has successfully commercialized the MIS screw, which is applied to the thoracic, lumbar spine and is supplying it to US and Korean markets.
The firm also previously gained the first ever U.S. FDA approval for a cervical MIS System in 2016, it said.
The latest approval adds to its existing products – creating a full lineup that allows of MIS operations from the top to bottom of the spine, according to the company.
“Through the product lineup, it is possible to introduce surgery through the MIS technique in all areas of the spine that serves as the body’s axis,” a company official said. “We anticipate sales growth due to changing surgical trends towards the MIS technique, which has more advantages than traditional surgical methods.”
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