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Stryker receives FDA clearance for OptaBlate™ Bone Tumor Ablation System

Wednesday, September 21, 2022

Stryker, one of the world's leading medical technology companies, announced today that its OptaBlate bone tumor ablation system (OptaBlate) received 510(k) clearance from the U.S. Food and Drug Administration. The addition of the OptaBlate technology to Stryker's Interventional Spine (IVS) portfolio expands on its core competencies in vertebral augmentation and radiofrequency ablation and completes its portfolio of treatment options for metastatic vertebral body fractures.

"Stryker's new bone tumor ablation (BTA) system is a significant improvement on existing technology and builds on Stryker's IVS portfolio," said Dr. Anthony Brown, a Vascular and Interventional Radiologist at Radiology Imaging Associates, CO. "There is no more deserving patient population for our attention and intervention; OptaBlate will change lives."

As Stryker's first Interventional Oncology technology, OptaBlate optimizes all aspects of the procedure—from set-up to ablation. Featuring four probes and Stryker's unique and patented microinfusion technology*, OptaBlate allows physicians to easily customize their procedure and reduce ablation time by three minutes.1

Specific key features of the system include:

    Treatment of two vertebral body levels at once using a bipedicular approach
    Quicker, more consistent ablation1
    Microinfusion technology, which keeps the zone hydrated, reducing impedance errors and preventing charring1

"Our commitment to our customers and understanding their needs has never been stronger. The collaboration has helped us to develop a more efficient bone tumor ablation system to address their unmet needs," said Greg Siller, Vice President and General Manager, Interventional Spine business, Stryker. "OptaBlate will help our customers provide another treatment option for those suffering from painful metastatic cancer, and this is just the beginning."

Stryker's Interventional Spine business will introduce its OptaBlate as part of its minimally invasive portfolio at the North American Spine Society Annual Meeting, Oct. 12-15, in Chicago, IL. (Booth #4211).

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