US EditionStryker Receives FDA Clearance for OptaBlate® BVN Basivertebral Nerve Ablation System
- On May 19, 2025, Stryker, based in Portage, Michigan, announced that the FDA had granted 510 clearance for its OptaBlate device designed to treat chronic vertebrogenic low back pain by targeting the basivertebral nerve.
- This clearance follows evidence from a five-year prospective randomized study showing sustained pain and function benefits in patients with chronic low back pain.
- OptaBlate BVN uses radiofrequency ablation with a steerable curved introducer and microinfusion technology to target the basivertebral nerve in a minimally invasive procedure.
- Kristen Berg, Stryker’s Interventional Spine leader, said they have a "long history in radiofrequency ablation" and aim to "promote quality of life" with this innovation.
- Stryker will introduce OptaBlate BVN at the ASPN Annual Meeting in Miami from July 17-20, expanding its pain portfolio to help patients avoid more aggressive treatments.
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Stryker receives FDA clearance for OptaBlate® BVN Basivertebral Nerve Ablation System – Ortho Spine News
Stryker’s first basivertebral nerve ablation system targets the basivertebral nerve to provide relief from chronic* vertebrogenic low back pain. PORTAGE, Mich., May 19, 2025 /PRNewswire/ — Stryker (NYSE:SYK), a global leader in medical technologies, announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) received 510(k) clearance from the U.S. Food and Drug Administration. OptaBlate BVNA is used in a targeted minimally in
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