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OSTEOCOOL RADIOFREQUENCY ABLATION SYSTEM

Device-Type

Ablation System

Targated Speciality

Cryoablation

Manufacturer

Medtronic


The OsteoCoolTM RF Ablation System is cooled radiofrequency (RF) ablation technology. It offers simultaneous, dual-probe capabilities for treating painful bone tumors.


  • 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.

Features and Benefits

The OsteoCool RF Ablation system is cooled radiofrequency (RF) ablation technology. It offers simultaneous, dual-probe capabilities for treating painful bone tumors.

Coaxial, bipolar technology delivers RF energy to the site, and automatically moderates power to keep RF heating within the desired treatment range. This reduces risk of potential thermal damage to adjacent tissue.

The active tip of the ablation probe is internally cooled with circulating water. RF energy heats the tissue while circulating water moderates the temperature close to the active tip. This combination:

  • Creates large volume lesions without excessive heating at the active tip
  • Minimizes potential for char

The OsteoCool RF ablation probes are sterile and intended for single use.


CUSTOMIZE YOUR ABLATIONS OPTIONS

OsteoCool can be utilized using one probe or two probes.

You’ll find flexibility with a wide range of ablation scenarios for your patient and procedural needs:

  • Metastatic and benign bone tumor ablation
  • Simultaneous ablation of adjacent or multiple levels in the spine
  • Simultaneous ablation using two probes, such as bipedicular spine tumor ablation
  • Ablation using one probe
  • Multiple active tip sizes and introducer gauge options
  • Custom ablation zones
  • Track ablation

Safety informations

The OsteoCool™ RF Ablation System is intended for ablation of benign bone tumors such as osteoid osteoma and for the palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body. It is also intended for 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.


Risks of the system include damage to surrounding tissue through iatrogenic injury as a consequence of electrosurgery; pulmonary embolism; nerve injury including thermal injury, puncture of the spinal cord or nerve roots potentially resulting in radiculopathy, paresis, and paralysis. The OsteoCool™ bone access kits are indicated for percutaneous access to bone.

Potential adverse events

  • As a consequence of electrosurgery, damage to surrounding tissue through iatrogenic injury could result
  • Pulmonary embolism
  • Nerve injury including thermal injury, puncture of spinal cord or nerve roots potentially results in radiculopathy, paresis, and paralysis


Device Documents

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