www.fdanews.com/articles/209495-stryker-receives-510k-clearance-for-its-optablate-system
Stryker Receives 510(k) Clearance for Its OptaBlate System
September 22, 2022
Stryker has received 510(k) clearance from the FDA for its OptaBlate bone tumor ablation system.
The four-probe system features the company’s patented microinfusion technology that is designed to keep the treated zone hydrated, reduce impedance errors and prevent charring.
The system, which is intended as a treatment option for patients with painful metastatic tumors, can reduce ablation time by three minutes, according to the company.
Stryker plans to launch the OptaBlate system at the North American Spine Society Annual Meeting in Chicago, Ill. Oct. 12-15.