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

Stryker has announced that its OptaBlate basivertebral nerve ablation (BVN) system has received 510(k) clearance from the US Food and Drug Administration (FDA).

The OptaBlate BVN system provides long-term relief from vertebrogenic pain using a precise, minimally invasive approach.

This clearance marks an important addition to Stryker’s growing pain management portfolio. By combining its expertise in radiofrequency ablation and vertebral access, Stryker aims to expand treatment options for patients suffering from chronic low back pain.

The procedure using OptaBlate BVN targets a specific source of back pain, especially in patients with identifiable signs on MRI scans. 

This is intended for individuals who have not found relief through standard treatments such as physical therapy, injections or medication.

The system offers several key features they including: Creates a lesion of at least 1 cm within seven minutes, Includes a steerable, dynamically curved introducer for precise targeting, Features microinfusion technology to hydrate the ablation zone, reducing errors and preventing charring, and Provides 10-gauge access tools for improved delivery

Stryker has a long-standing presence in radiofrequency ablation and continues to focus on developing innovative solutions aimed at improving quality of life. 

The OptaBlate BVN system is designed to meet the needs of patients living with chronic vertebrogenic lumbar pain, a condition that often lacks effective long-term treatment options.