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Stryker has announced that it has obtained FDA 510(k) clearance for its OptaBlate basivertebral nerve ablation system (OptaBlate BVN).

Headquartered in Portage, Michigan, Stryker developed OptaBlate BVN for a minimally invasive, targeted procedure intended to deliver long-term relief from vertebrogenic pain. The company states that incorporating OptaBlate BVN into its pain management portfolio strengthens its offering of advanced pain therapy options. It also reflects the convergence of two of Stryker’s key capabilities — radiofrequency (RF) ablation and vertebral access.

Dr. Jad Khalil, a spine surgeon with Michigan Orthopaedic Surgeons, believes that OptaBlate BVN may overcome the shortcomings of current treatment options. He explains that individuals suffering from chronic low back pain often pursue physical therapy, injections, or medications, yet still fail to achieve sustained relief.

“BVNA is a minimally invasive and innovative procedure that targets a key source of this pain, particularly in patients with specific MRI findings,” Khalil said. “Before BVNA, options for lasting relief were limited. For many, it offers meaningful improvement and can help avoid more aggressive treatments like surgery.”

Stryker notes that the system is capable of ablating a lesion of at least 1 cm in just seven minutes. It includes a steerable, dynamically curved introducer for enhanced targeting. Equipped with 10-gauge access tools, the system also utilizes microinfusion technology that maintains hydration in the treatment area, helping to reduce impedance issues and avoid charring.

“We have a long history in radiofrequency ablation, and we’re relentlessly committed to delivering groundbreaking approaches to protect and promote quality of life,” said Kristen Berg, VP and GM of Stryker’s Interventional Spine business. “Our legacy providing solutions to reduce pain now continues with OptaBlate BVN, addressing the underserved population suffering from chronic vertebrogenic lumbar pain.”

Source: Stryker Corporation