01.20.15
Zyga Technology Inc. has enrolled its first patient enrollment in the EVoluSIon study, a multicenter single-arm trial designed to evaluate fusion and pain reduction with the use of its SImmetry Sacroiliac Joint Fusion System.
The EVoluSlon study will be performed at 10 U.S. sites and will include up to 50 patients.
"The SImmetry technology helps provide an environment for symptom relief to sacroiliac joint fusion patients," said Gowriharan "Ty" Thaiyananthan, M.D., founder and head neurosurgeon at Newport Beach, Calif.-based BASIC Spine, who performed the surgery. "It enables me to perform a true fusion, including decortication and bone grafting, through an efficient, minimally invasive approach; the procedure was completed in 30 minutes and the patient went home the next morning."
The U.S. Centers for Disease Control and Prevention lists lower back pain as the second most common cause of disability in U.S. adults. Roughly 20 percent of all chronic low back pain derives from the sacroiliac joint.
"The SImmetry system offers a surgical solution for patients suffering from sacroiliac joint dysfunction," said Jim Bullock, president and CEO of Zyga. "The EVoluSIon study, along with our SAIF (Sacroiliac Joint Fusion System) study and additional ongoing clinical research, will be critical to demonstrate clinical value and assist with proper utilization of this new surgical option."
On Jan. 1, the American Medical Association CPT Panel approved a Category I CPT code for Minimally Invasive Sacroiliac Joint Fusion, providing validation that current clinical data support efficacy of the procedure and improving patient access to the surgery.
Based in Minneapolis, Minn., Zyga Technology develops minimally invasive surgical spinal solutions. The company was founded in 2008.
The EVoluSlon study will be performed at 10 U.S. sites and will include up to 50 patients.
"The SImmetry technology helps provide an environment for symptom relief to sacroiliac joint fusion patients," said Gowriharan "Ty" Thaiyananthan, M.D., founder and head neurosurgeon at Newport Beach, Calif.-based BASIC Spine, who performed the surgery. "It enables me to perform a true fusion, including decortication and bone grafting, through an efficient, minimally invasive approach; the procedure was completed in 30 minutes and the patient went home the next morning."
The U.S. Centers for Disease Control and Prevention lists lower back pain as the second most common cause of disability in U.S. adults. Roughly 20 percent of all chronic low back pain derives from the sacroiliac joint.
"The SImmetry system offers a surgical solution for patients suffering from sacroiliac joint dysfunction," said Jim Bullock, president and CEO of Zyga. "The EVoluSIon study, along with our SAIF (Sacroiliac Joint Fusion System) study and additional ongoing clinical research, will be critical to demonstrate clinical value and assist with proper utilization of this new surgical option."
On Jan. 1, the American Medical Association CPT Panel approved a Category I CPT code for Minimally Invasive Sacroiliac Joint Fusion, providing validation that current clinical data support efficacy of the procedure and improving patient access to the surgery.
Based in Minneapolis, Minn., Zyga Technology develops minimally invasive surgical spinal solutions. The company was founded in 2008.