Advancing bone tumor ablation through clinical evidence.
OpuS One Post-Market Study1: 100 Patients Treated with OsteoCool™ RF Ablation. The ongoing study demonstrates pain relief* that is:
Unmatched commitment to the advancement of BKP therapy, and to thinking beyond the procedure.
Levy J, Hopkins T, Morris J, et al. Abstract No. 346. Radiofrequency ablation for the palliative treatment of bone metastases: outcomes from a multicenter study in 100 patients. J Vasc Intervent Radiol. 2020;31(3 Supplement):S158. doi: https://doi.org/10.1016/j.jvir.2019.12.404.
Pre-ablation worst pain was 8.2 decreasing to 5.6 (n=94) at 3 days, 4.7 (n=89) at 1 week, 3.9 (n=64) at 1 month, 3.7 (n=46) at 3 months, and 3.5 (n=22) at 6 months. P<0.0001 all visits.
The complication rate with KyphonTM Balloon Kyphoplasty has been demonstrated to be low. There are risks associated with the procedure (e.g., cement extravasation), including serious complications, and though rare, some of which may be fatal.
Risks of acrylic bone cements include cement leakage, which may cause tissue damage, nerve or circulatory problems, and other serious adverse events such as:
For complete information regarding indications for use, contraindications, warnings, precautions, adverse events, and methods of use, please reference the devices' Instructions for Use included with the product.