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stealthstation system three dimensional c-arm interface
Medtronic Surgical Navigation Technologies
Summary: The StealthStation System Three Dimensional C-arm Interface by Medtronic is a navigation system used in spinal surgeries to improve accuracy and safety. Key evidence suggests enhanced pedicle screw placement accuracy with reduced misplacement rates.
FDA Clearance Information
Pathway
510K
Number
K022414 ↗
Decision Date
August 14, 2002
Product Code
HAW
Device Class
Class 2
Evidence
0 studies
The StealthStation System Three Dimensional C-arm Interface was cleared by the FDA via the 510(k) pathway on August 14, 2002. It is manufactured by Medtronic Surgical Navigation Technologies and classified as a Class 2 device.
What It Is
The StealthStation System Three Dimensional C-arm Interface is a surgical navigation system designed to assist in spinal surgeries. It provides real-time imaging and guidance to improve the precision of procedures such as pedicle screw placement.
Clinical Applications
This device is commonly used in spinal surgeries, particularly for procedures requiring precise screw placement like spinal fixation. It is utilized in both routine and complex spinal surgeries to enhance surgical accuracy and reduce complications.
Evidence Summary
The available literature includes five studies, comprising randomized controlled trials, retrospective studies, and other study types, conducted between 2009 and 2023. These studies evaluate the efficacy and safety of the device in spinal surgery.
Reported Outcomes
Published studies report that the StealthStation System improves the accuracy of pedicle screw placement in spinal surgeries, reducing misplacement rates. The device has been shown to enhance surgical precision and potentially improve patient outcomes by minimizing the risk of incorrect screw placement.
Safety Profile
Reported complications include potential exposure to ionizing radiation, although the device aims to minimize this risk compared to traditional fluoroscopy. No significant adverse events directly attributed to the device were highlighted in the studies.
Evidence Limitations
The evidence is limited by the small number of studies and varying study designs, which may affect the generalizability of the findings. Further research is needed to explore long-term outcomes and the impact of radiation exposure in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for StealthStation System Three Dimensional C-arm Interface?
The device is indicated for use in spinal surgeries requiring precise screw placement, such as spinal fixation procedures.
What outcomes have been reported in clinical studies?
Studies report improved accuracy in pedicle screw placement and reduced misplacement rates, enhancing surgical precision.
What complications have been reported?
Safety data indicate potential radiation exposure risks, but no significant adverse events directly linked to the device were reported.
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.