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Stryker’s OptaBlate BVN System Earns FDA Clearance for Chronic Back Pain Relief

A New Solution for Chronic Back Pain.

Stryker has received FDA 510(k) clearance for its OptaBlate Basivertebral Nerve Ablation (BVN) system. This minimally invasive device targets chronic vertebrogenic low back pain by disrupting signals from the basivertebral nerve. The pain is commonly associated with degenerative changes in spinal vertebrae, which often resist traditional treatment options.

The Impact of Vertebrogenic Pain.

Vertebrogenic low back pain affects millions of adults across the world. Standard therapies like medication and physical therapy often provide limited relief. Stryker’s new system gives these patients a novel, clinically-backed option to address their persistent discomfort. The technology is aimed at reducing reliance on opioids and delaying more aggressive treatments like surgery.

Technology Behind the OptaBlate BVN System.

OptaBlate is engineered for precision and ease of use in outpatient settings. It creates a controlled 1 cm lesion within about seven minutes, targeting the pain-transmitting nerve. The system includes a steerable, curved introducer to accurately reach the vertebral target site. Stryker’s microinfusion technology also keeps tissues hydrated, preventing burn errors and maintaining effective impedance levels. It uses standard 10-gauge access tools, minimizing patient discomfort while allowing safe and effective ablation.

Expert Opinions on Innovation.

Dr. Jad Khalil, a Michigan-based orthopedic spine surgeon, praised the system’s potential impact. He emphasized that patients with specific MRI findings could experience meaningful, lasting relief. The system, he added, can help avoid more complex surgical procedures in many cases.

Corporate Strategy and Market Goals.

Kristen Berg, Stryker’s Interventional Spine VP and GM, shared the company’s intent. She noted that OptaBlate BVN will address an underserved group of chronic pain sufferers. Stryker aims to expand minimally invasive options that enhance quality of life for patients.

Upcoming Launch and Industry Preview.

The company will showcase the system at the American Society of Pain & Neuroscience Annual Meeting in July. The Miami event will allow healthcare professionals to see the technology in action.

Conclusion.

Stryker’s FDA-approved OptaBlate BVN system signals a promising advance in back pain management. By combining innovation with accessibility, the device offers hope to patients and physicians alike.

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