OsteoCool Tumor Ablation Post-Market Study

The OsteoCool™ RF Ablation system has 510k regulatory clearance in the United States,
Conformité Européene (CE) mark in Europe, and Health Canada Licence in Canada. The goal of
this study is to collect real-world outcomes among a cohort of patients in the US, EUR and
CAN with metastatic malignant lesions in a vertebral body, painful metastatic lesions
involving bone (in the US, patients with metastatic lesions involving the bone must have
failed or were not candidates for standard therapy), and benign bone tumors such as osteoid
osteoma who receive treatment with the OsteoCool™ RF Ablation system. Additionally, the study
will collect device, procedure and/or therapy related adverse events and device deficiencies.
Lastly, subject outcomes (such as pain relief, quality of life, and function) will be
evaluated using validated assessment measures.

Inclusion Criteria:

1. Candidate for OsteoCool RF ablation per the labeled indication applicable in their
respective country/region

2. A. Metastatic lesions targeted for treatment must be located in the thoracic and/or
lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone
tumors - no restrictions on location of lesion

3. Report worst pain score ≥4/10 at the target treatment site within the past 24 hours

4. Localized pain resulting from no more than two sites total of metastatic disease

5. Have Karnofsky score ≥40 at enrollment (not applicable for subjects with benign bone
tumors)

6. Willing and able to provide a signed and dated informed consent, comply with the study
plan, follow up visits and phone calls

7. At least 18 years old at the time of informed consent

Exclusion Criteria:

1. A. Implanted with heart pacemaker or other implanted electronic device (Europe and
Canada only)

2. Use of OsteoCool in vertebral body levels C1-C7

3. Multiple myeloma, solitary plasmacytoma, or primary malignant lesions in the index
vertebra or bone

4. Active or incompletely treated local infection at the planned treatment site(s) and/or
systemic infection

5. Planned treatment site(s) accompanied by objective evidence of secondary radiculopathy
or neurologic compromise

6. Planned treatment site(s) associated with spinal cord compression or canal compromise
requiring decompression

7. Fractures due to prostatic cancer or other osteoblastic metastases to the spine.
Metastatic lesions originating in the prostate that are osteolytic or mixed origin are
eligible for the study

8. Pregnant, breastfeeding, or plan to become pregnant during the study duration

9. Concurrent participation in another clinical study that may add additional safety
risks and/or confound study results*

10. Any condition that would interfere with the subject's ability to comply with study
instructions or might confound the study interpretation

- Subjects in concurrent studies can only be enrolled with permission from
Medtronic. Please contact Medtronic's study manager to determine if the subject
can be enrolled in both studies.