SynerFuse has announced that—for the first time in the world, it claims—a solo spine surgeon has performed the SynerFuse procedure in a two-level spinal fusion patient.
Rohan Lall (M Health Fairview, Minneapolis, USA) performed the procedure and implanted a neurostimulator system in the 10th patient in a proof-of-concept study evaluating the safety and feasibility of this investigational, integrated approach.
“So far in the study, the SynerFuse procedure has been efficient and straightforward to perform, including in the context of a two-level fusion,” said Lall. “It is very exciting to study the integration of DRG [dorsal root ganglion] stimulation to the fusion surgery for patients with chronic pain earlier in the treatment process in an attempt to reduce their pain levels and need for opioids.”
The SynerFuse proof-of-concept study involves combining spinal fusion with the implant of a neurostimulator to provide stimulation of the DRG—a key nerve structure along the spine that can be targeted with neuromodulation to treat neuropathic pain in patients suffering from chronic lower back pain (CLBP).
“The implantation of the 10th patient in our proof-of-concept study is an important milestone for SynerFuse and our goal of commercialisation,” said SynerFuse CEO Justin Zenanko. “With each new patient, we hope to be one step closer to demonstrating the viability of our non-narcotic therapy concept for spinal fusion patients with CLBP. We are looking forward to seeing the long-term outcomes as the data will be used to inform our next clinical trial using our novel device.”