Gimer Medical today announced that the company’s spinal cord stimulation (SCS) system was granted conditional investigational device exemption (IDE) approval by US Food and Drug Administration (FDA) on 13 August.
According to a company press release, Gimer is now moving to human clinical studies and will begin enrolment at US trial sites soon.
Gimer’s implantable NeuroBlock SCS system provides effective pain management by releasing a novel, high-frequency stimulation of 500kHz to the spinal cord, and is based around the company’s patented +RF technology.
In 2008, the founders of Gimer combined pulsed radiofrequency (PRF) techniques to create +RF therapy. The release notes that this innovation provides a safer, paraesthesia-free and prolonged treatment for patients suffering from chronic pain, such as low-back or leg pain.
“Low-back pain is the second most common neurological symptom in the USA. It tortures patients physically and mentally,” said Rex Chi-Heng Chang, the CEO of Gimer. “The current treatment options are surgery, medication, and interventional pain management. At Gimer, we have devoted ourselves to providing a less invasive, cost-effective and drug-free treatment alternative to disrupt the pain market.”