đź“Š Evidence-Based Reference
pressure wire sensor 014 pressure wire interface 10 pressure wire monitor cable
Radi Medical Systems Ab
Summary: The pressure wire sensor by Radi Medical Systems Ab is used for measuring intravascular pressure. It is primarily used in assessing coronary artery disease. Key evidence highlights its effectiveness in fractional flow reserve measurements.
FDA Clearance Information
Pathway
510K
Number
K972793 ↗
Decision Date
April 24, 1998
Product Code
DQX
Device Class
Class 2
Evidence
0 studies
The pressure wire sensor was cleared by the FDA through the 510(k) pathway on April 24, 1998. It is manufactured by Radi Medical Systems Ab and classified as a Class 2 device.
What It Is
The pressure wire sensor is a device designed to measure intravascular pressure, aiding in the assessment of coronary artery disease. It operates by interfacing with a pressure wire monitor cable to provide accurate physiological measurements.
Clinical Applications
This device is commonly used in interventional cardiology to evaluate coronary artery stenosis and guide revascularization decisions. It is particularly useful in fractional flow reserve (FFR) measurements to assess the severity of coronary lesions.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective studies, and case series. The studies span from 2012 to 2024, providing a comprehensive overview of the device's clinical utility.
Reported Outcomes
Published studies report that the pressure wire sensor is effective in providing accurate fractional flow reserve measurements, which are crucial for assessing coronary artery disease. The device has been shown to improve decision-making in revascularization procedures.
Safety Profile
Reported complications include potential errors in pressure measurements, which can be mitigated with automated correction methods. Overall, the device is considered safe with no significant adverse events reported in the literature.
Evidence Limitations
Some studies highlight the need for further research on the device's performance in diverse patient populations. Additionally, there is a need for more data on long-term outcomes and comparisons with newer technologies.
Frequently Asked Questions
What are the clinical indications for the pressure wire sensor?
The pressure wire sensor is indicated for use in measuring intravascular pressure, particularly in the assessment of coronary artery disease and guiding revascularization decisions.
What outcomes have been reported in clinical studies?
Clinical studies have reported that the device provides accurate fractional flow reserve measurements, aiding in the assessment of coronary lesions and improving revascularization decision-making.
What complications have been reported?
Safety data from evidence indicate potential errors in pressure measurements, which can be corrected automatically. No significant adverse events have been 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.