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FDA grants Medtronic expanded indication for cancer-fighting OsteoCool Ablation System — 7 takeaways Featured

Written by  Adam Schrag | Wednesday, 15 February 2017 18:57
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Dublin-based Medtronic's OsteoCool System has been granted expanded FDA clearance to treat cancer in all bones rather than just the spine.

Here are seven things to know:

 

1. Although the OsteoCool System was originally only cleared for use in the spine, the FDA has now cleared it to be used as a palliative treatment of metastases in all bones for patients who haven't benefited from standard therapies.

 

2. The system uses targeted radiofrequency energy to remove malignant metastatic bone tumors. The expanded clearance will most likely impact the system's use on rib, sacrum, extremity and hip treatment.  

 

3. Sandeep Bagla, MD, of the Vascular Institute of Virginia in Woodbridge, Va., says: "With the expanded indication for the OsteoCool System, I now have the option to ablate…patients' painful bone tumors when conventional therapies are considered ineffective, too slow-acting or cause unacceptable side effects."

 

4. Approximately 60 to 80 percent of cancer patients have metastatic bone disease, with the ailment most often affecting patients with primary malignancies of the breast, prostate, liver and lung.  

 

5. Over 80 percent of bone metastases occur in skull, spine and ribs.

6. Medtronic acquired the OsteoCool technology from Montreal-based Baylis Medical in 2015 and partnered with the Canadian company to continue improving the system.  

 

7. OsteoCool is temperature controlled and prevents overheating of surrounding tissues during the procedure thanks to internal water-cooled probes.

 

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