Justin Zenanko, the CEO of SynerFuse, has announced that—in what the company says is a world-first—a solo spine surgeon has performed the “groundbreaking” SynerFuse procedure.
Rohan Lall (M Health Fairview, Minneapolis, USA) simultaneously performed both a spinal fixation procedure and implanted a neurostimulator with leads on the eighth patient in the company’s proof-of-concept study, according to a press release.
“So far in the study, the SynerFuse procedure has been efficient and straightforward to perform,” said Lall. “The industry has seen the efficacy of DRG [dorsal root ganglion] stimulation for patients with chronic pain, and it is very exciting to be able to study incorporating it earlier in the treatment process for these patients in an attempt to reduce their pain levels and needs for opioids. I believe this will become widely adopted in spine surgery.”
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 chronic neuropathic pain, providing relief to patients suffering from chronic lower back pain (CLBP). Patients undergoing an initial spinal fusion, among other criteria, are eligible for the study. The SynerFuse proof-of-concept study supports the enrolment of up to 20 patients, the release adds.
“This is an important step toward demonstrating that our combined procedure can be performed without needing two surgeons,” said Zenanko. “Spinal fixation procedures today are performed by one spine surgeon. This study aims to conclude that one spine surgeon can also perform the integrated SynerFuse procedure. This is an important step toward adoption of the procedure.
“The implantation of the eighth patient in our proof-of-concept study is an important milestone for SynerFuse. With each new patient, we are one step closer to demonstrating the viability of our non-narcotic concept for spinal fusion patients with chronic lower back pain.”
“Bringing this patient-focused therapy from concept to the eighth implant is a true testament to collaboration within our company, and with our surgeon and staff partners at the University of Minnesota Medical School and M Health Fairview University of Minnesota Medical Center,” added SynerFuse co-founder and chief scientific officer Greg Molnar.
Previously in the proof-of-concept study, seven patients had a neurostimulator with leads implanted by Michael Park (M Health Fairview, Minneapolis, USA), and spinal fixation by Lall and Jonathon Sembrano (M Health Fairview, Minneapolis, USA) at M Health Fairview University of Minnesota Medical Center in Minneapolis, USA.