Dive Brief:
- Stryker has received 510(k) clearance for a minimally invasive back pain treatment, positioning it to challenge Boston Scientific for the market.
- The Food and Drug Administration clearance, which Stryker disclosed Monday, covers the use of the OptaBlate basivertebral nerve ablation system to provide relief for low back pain.
- Stryker is entering a growing market. Boston Scientific’s rival device, which it acquired for $850 million upfront in 2023, “grew strong double digits” in the first quarter, CEO Mike Mahoney told investors in an April earnings call.
Dive Insight:
Stryker received 510(k) clearance in 2022 for an OptaBlate device to manage malignant spine lesions and the pain they can cause. The latest clearance expands use of the OptaBlate platform to the management of chronic vertebrogenic low back pain. Patients develop the condition when the endplates on their vertebrae are damaged and send signals to the brain.
Basivertebral nerve ablation is a minimally invasive procedure for treating the form of low back pain. The procedure targets the nerve that carries the pain signals to the brain. Physicians can block the signals by using radiofrequency energy to create a lesion at the base of the nerve.
Stryker said its device achieves at least a 1 cm lesion in seven minutes. Stryker, which developed OptaBlate internally, said the device brings together its expertise in radiofrequency ablation technology and vertebral access.
OptaBlate is entering a market already served by Boston Scientific’s Intracept. Relievant Medsystems received 510(k) clearance for Intracept for the ablation of basivertebral nerves in 2016. Boston Scientific bought Relievant in 2023, paying $850 million upfront and committing to success-based payments that could move the total value of the deal above $1 billion.
Boston Scientific forecast sales of $70 million in 2023 and predicted year-over-year growth of more than 50% in 2024. The company has tipped the device to drive growth at its pain franchise in 2025, driven by five-year data on the effectiveness of the treatment.
