Stryker Receives FDA Clearance for OptaBlate® BVN Basivertebral Nerve Ablation System

SYK
October 04, 2025

On May 19, 2025, Stryker announced that its OptaBlate basivertebral nerve ablation system (OptaBlate BVN) received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This system is designed for a targeted, minimally invasive procedure that provides long-lasting relief from chronic vertebrogenic low back pain. The clearance expands Stryker's advanced pain therapy solutions portfolio.

The OptaBlate BVN system represents an intersection of Stryker's core competencies in radiofrequency ablation technology and vertebral access. Dr. Jad Khalil, Spine Surgeon at Michigan Orthopaedic Surgeons, highlighted that BVNA offers a meaningful improvement for patients who have not found lasting relief from other treatments, potentially helping them avoid more aggressive interventions like surgery.

Key features of the system include its ability to achieve at least a 1-centimeter lesion in seven minutes and its microinfusion technology, which reduces impedance errors and prevents charring. Kristen Berg, Vice President and General Manager of Stryker's Interventional Spine business, emphasized the company's commitment to delivering groundbreaking approaches to reduce pain. Stryker plans to introduce OptaBlate BVN as part of its pain portfolio at the American Society of Pain & Neuroscience Annual Meeting in July.

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