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September 21, 2022

Stryker’s bone tumour ablation system receives FDA 510(k) clearance

The OptaBlate system allows physicians to easily customise their procedure and reduces ablation times by three minutes.

Stryker has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its OptaBlate bone tumour ablation system.

OptaBlate has been designed to optimise all aspects of the procedure, from set-up to ablation, and allows physicians to easily customise their procedure.

It helps to reduce ablation times by three minutes.

Claimed to be Stryker’s first interventional oncology technology, the OptaBlate system features four probes and uses the company’s patented microinfusion technology.

This technology keeps the zone hydrated to reduce impedance errors and prevent charring.

Using a bipedicular approach, the system treats two vertebral body levels at the same time.

Stryker stated that adding the system to its interventional spine portfolio expands the core competencies of the company in vertebral augmentation and radiofrequency ablation.

The device also completes the company’s portfolio of treatment options to treat metastatic vertebral body fractures.

Stryker Interventional Spine business vice-president and general manager Greg Siller said: “Our commitment to our customers and understanding their needs has never been stronger.

“The collaboration has helped us to develop a more efficient bone tumour ablation system to address their unmet needs.

“OptaBlate will help our customers provide another treatment option for those suffering from painful metastatic cancer, and this is just the beginning.”

The company intends to launch the OptaBlate system next month, at the North American Spine Society Annual Meeting in Chicago, Illinois, US.

Recently, Stryker launched its new Gamma4 System for the treatment of stable and unstable fractures.

The new Gamma System provides surgeons with the company’s next-generation intramedullary nailing system.

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