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OSTEOCOOL™ RF ABLATION CLINICAL EVIDENCE

Learn more about the OPuS One clinical trial, a post-market study for OsteoCool™ radiofrequency ablation.
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   Indications, Safety, and Warnings

Osteocool RF Ablation webinar - November recording

NEW OPUS ONE CLINICAL RESULTS

OUTCOMES IN 206 PATIENTS TREATED WITH OSTEOCOOL™ RF ABLATION

opus one 12 month study results demonstrated pain relief and improvement of Quality of Life1-3 that was:

SWIFT 3 Days Post-Procedure1

SIGNIFICANT IMPROVEMENTS AT ALL VISITS2

SUSTAINED THROUGH 12 MONTHS3

Pain Relief

Chart showing a decrease in pain over the course of six months. Pain levels were rated at 8.2 out of 10 pre-ablation, and then 3.5 six months after ablation.

OPuS One: Outcomes from 206 patients treated with up to 12 months follow-up.

OPUS ONE SUMMARY

Quality of Life

Chart showing an increase in quality of life over the course of twelve months. Quality of life increased from 0.50 to 0.74 over that period of time..

OPuS One: Published primary manuscript from first 100 patients treated.

DOWNLOAD PUBLICATION

Study Design

The OsteoCool Post-Market Study, “OPuS One,” is a prospective multicenter study in the United States, Europe, and Canada. The goal of the study is to collect real-world outcomes on effectiveness and safety among a cohort of patients who have been treated with the OsteoCool™ RF ablation system.

OsteoCool image with dual probes.

OBJECTIVES OF THE 12-MONTH ANALYSIS:

  • To characterize change in pain scores and quality of life from baseline through 12 months in patients with metastatic bone lesions of the spine.

MEASUREMENTS:

  • Pain
  • Function
  • Quality of life
  • Medication

POST PROCEDURE FOLLOW-UP:

  • 3 days
  • 1 week
  • 1-, 3-, 6-, and 12- months
Additional study details

IMPORTANT SAFETY INFORMATION

INDICATIONS

  • Intended for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body
  • Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy
  • Ablation of benign bone tumors such as osteoid osteoma

RISKS

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could occur
  • Pulmonary embolism

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1

Levy J, Hopkins T, Morris J, et al. Radiofrequency Ablation for the Palliative Treatment of Bone Metastases: Outcomes from the Multicenter OsteoCool Tumor Ablation Post-Market Study (OPuS One Study) in 100 Patients. J Vasc Interv Radiol 2020; 31:1745–1752. https://doi.org/10.1016/j.jvir.2020.07.014

2

Levy J, David E, Hopkins T, et al. Radiofrequency Ablation for the Palliative Treatment of Osseous Metastases: Final Results from a Multicenter Study (OPuS One). Abstract at Society for Interventional Radiology Annual Scientific Meeting 2021.

3

Levy J, David E, Hopkins T, et al. Improvement In Quality Of Life In Patients Treated For Painful Osseous Metastases With Radiofrequency Ablation: The Opus One Study. Abstract at Society for Interventional Radiology Annual Scientific Meeting 2021.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu