đź“Š Evidence-Based Reference
Atricure Cryoice Cryosphere Cryoablation Probe
Summary: The AtriCure CryoICE Cryosphere Cryoablation Probe is a medical device used for cryoablation procedures. It is primarily used in surgical settings for tumor ablation. Current evidence includes two studies focusing on postoperative pain management and cryoanalgesia.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K182565 ↗
Decision Date ?
November 9, 2018
Product Code ?
GXH
Device Class ?
Class 2
Evidence ?
0 studies
The AtriCure CryoICE Cryosphere Cryoablation Probe was cleared by the FDA via the 510(k) pathway on November 9, 2018. It is manufactured by Atricure and classified as a Class 2 device under product code GXH.
What It Is
The AtriCure CryoICE Cryosphere Cryoablation Probe is designed for cryoablation, a technique that uses extreme cold to destroy tissue. It is intended for use in surgical procedures requiring precise ablation of tissue, such as tumor removal.
FDA-Cleared Indications
- For use in the practice of cryosurgery to ablate tissue during surgical procedures.
- For use in cryoanalgesia to provide temporary relief of pain by freezing targeted peripheral nerves during surgery.
Clinical Applications
- Surgical cryoablation of targeted soft tissue.
- Intraoperative cryoanalgesia of peripheral nerves to reduce postoperative pain.
- Cryoanalgesia during minimally invasive thoracic procedures, when consistent with the device labeling and surgical plan.
Reported off-label uses
- Cryoablation of selected tumors or tumor margins in surgical oncology, when performed outside the device's specific FDA-cleared labeling.
- Postoperative intercostal nerve cryoablation for longer-lasting pain control in selected thoracic operations.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes two clinical studies registered on ClinicalTrials.gov. These studies focus on postoperative pain management and cryoanalgesia, though specific details on sample sizes and outcomes are not provided.
Reported Outcomes
Published studies report the use of the AtriCure CryoICE Cryosphere Cryoablation Probe in managing postoperative pain and providing cryoanalgesia. However, specific efficacy outcomes are not detailed in the available evidence.
Safety Profile
Reported complications include potential risks associated with cryoablation procedures, though specific adverse events are not detailed in the provided studies. Further research is needed to fully understand the safety profile.
Evidence Limitations
The current evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to establish comprehensive efficacy and safety profiles for the device.
Practical Considerations
- The probe is designed for use during surgery and requires compatible cryogenic equipment, tubing, and accessories specified by the manufacturer.
- Probe dimensions and the active freezing area vary by model; the exact size should be confirmed in the current device labeling before use.
- The operator must avoid unintended freezing of adjacent organs, vessels, nerves, skin, and other structures. Protective insulation, controlled probe placement, and direct visualization may be required.
- MRI safety and conditional-use information should be verified in the current AtriCure labeling; the probe and connected cryogenic system should not be assumed to be MRI safe.
- Potential complications include unintended tissue injury, bleeding, infection, nerve damage, prolonged numbness, and pain recurrence. Contraindications and warnings in the current instructions for use apply.
Frequently Asked Questions
What are the clinical indications for AtriCure CryoICE Cryosphere Cryoablation Probe?
The device is indicated for use in cryoablation procedures, particularly in surgical oncology for tumor ablation and in managing postoperative pain through cryoanalgesia.
What outcomes have been reported in clinical studies?
The studies focus on postoperative pain management and cryoanalgesia, but specific efficacy outcomes are not detailed.
What complications have been reported?
Reported complications include general risks associated with cryoablation, though specific adverse events are not detailed in the available evidence.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.