SynerFuse has announced that Michael Park (University of Minnesota, Minneapolis, USA)—principal investigator for the company’s investigational device exemption (IDE) proof-of-concept study—presented data from the study’s first eight patients at the 10th annual Minnesota Neuromodulation Symposium (20–21 April, Minneapolis, USA).
“This presentation showcased the promising surgical procedure results to date of the world’s first SynerFuse implants integrating spinal fusion with neuromodulation of the dorsal root ganglia (DRG) in patients with chronic neuropathic pain of the low back or leg,” said Justin Zenanko, CEO of SynerFuse.
Spine surgeons Rohan Lall (M Health Fairview, Minneapolis, USA) and Jonathan Sembrano (University of Minnesota, Minneapolis, USA) performed the implants, with Park and Lall also performing the world’s first solo SynerFuse implant, as per a company press release.
“The study surgical procedure data presented today [21 April] showed that, in these eight patients—average follow-up 7.8 months—there were no infections, device failures with loss of stimulation therapy, or lead migrations associated with the novel integrated implant offering surgeons visual and direct access in placing leads on the DRG,” added Zenanko.
The recent SynerFuse press release also notes that enrolment in the study, which has been set up to evaluate the safety and tolerability of simultaneous implantation of spinal fusion and neuromodulation devices in chronic lower back pain patients, is currently ongoing.