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atricure cryoice cryosphere cryoablation probe
Atricure
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 510K
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.
Clinical Applications
This device is commonly used in surgical oncology for the ablation of tumors. It is also utilized in procedures where cryoanalgesia is required to manage postoperative pain, particularly in minimally invasive surgeries.
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.
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.