Stryker Enters Minimally Invasive Back Pain Treatment Market with FDA Clearance

Stryker Corporation has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its OptaBlate basivertebral nerve ablation system, marking the company's entry into the growing market for minimally invasive back pain treatments. This development positions Stryker to compete directly with Boston Scientific's Intracept device, setting the stage for increased competition in the chronic vertebrogenic low back pain management sector.

OptaBlate System: A New Player in Back Pain Management

The OptaBlate system, designed for the management of chronic vertebrogenic low back pain, utilizes radiofrequency ablation technology to target the basivertebral nerve. This nerve is responsible for transmitting pain signals from damaged vertebral endplates to the brain. Stryker's device can create a lesion of at least 1 cm in just seven minutes, effectively blocking these pain signals.

This latest FDA clearance expands the use of Stryker's OptaBlate platform, which previously received clearance in 2022 for managing malignant spine lesions and associated pain. The company's internal development of OptaBlate leverages its expertise in both radiofrequency ablation technology and vertebral access.

Market Competition and Growth Prospects

Stryker's entry into this market segment puts it in direct competition with Boston Scientific, which acquired Relievant Medsystems and its Intracept device for $850 million upfront in 2023. The acquisition deal included potential success-based payments that could push the total value beyond $1 billion.

Boston Scientific has reported strong performance for the Intracept device, with CEO Mike Mahoney noting "strong double-digit" growth in the first quarter of the current year. The company had forecast sales of $70 million for Intracept in 2023 and predicted year-over-year growth exceeding 50% in 2024.

The market for minimally invasive back pain treatments is showing significant potential, driven by long-term clinical data supporting the effectiveness of basivertebral nerve ablation. Boston Scientific has highlighted five-year data on treatment effectiveness as a key driver for growth in its pain franchise for 2025.

As Stryker and Boston Scientific vie for market share in this expanding segment, patients suffering from chronic vertebrogenic low back pain may benefit from increased treatment options and potential advancements in minimally invasive procedures.