PreludeSYNC Radial Compression Device
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FDA Clearance Information
FDA-Cleared Indications
- Used to assist hemostasis of the radial artery access site after catheter-based procedures.
- Intended for use following transradial arterial catheterization and other procedures requiring percutaneous radial artery access.
Clinical Applications
- Compression of a radial artery puncture site after diagnostic cardiac catheterization.
- Compression after transradial percutaneous coronary intervention.
- Hemostasis after other catheter-based procedures performed through radial artery access.
- Temporary compression of the radial access site while monitoring hand perfusion.
Practical Considerations
- The device is applied directly over the radial artery access site and adjusted to provide hemostasis without unnecessary pressure.
- Correct positioning and gradual pressure adjustment are important to reduce the risk of bleeding, hematoma, nerve compression, or impaired hand perfusion.
- It is a vascular compression device, not a permanent implant; it is removed after hemostasis is established according to the facility's protocol.
- Size and configuration should be selected according to the patient's wrist anatomy and the manufacturer's instructions for use.
- MRI safety should be confirmed in the current manufacturer labeling before the device is taken into an MRI environment; the device is generally removed before imaging.
Procedures that use this device
Frequently Asked Questions
What is the PreludeSYNC Radial Compression Device used for?
It is used to apply controlled compression over the radial artery puncture site after transradial catheterization or another radial-access procedure. Its purpose is to help stop bleeding and achieve hemostasis.
Is the PreludeSYNC Radial Compression Device MRI safe?
MRI safety should be checked in the current manufacturer labeling. Because the device is normally removed after the access site has stopped bleeding, it is generally not present during MRI.
What sizes does the PreludeSYNC device come in?
Available sizes and configurations depend on the specific product version and labeling. Clinicians should select the size that fits the patient's wrist and follow the manufacturer's instructions for use.
How long does the PreludeSYNC Radial Compression Device stay on?
The time varies with the access-site size, anticoagulation, bleeding risk, and institutional protocol. It is removed after adequate hemostasis is confirmed, often during the post-procedure recovery period.
How much does the PreludeSYNC Radial Compression Device cost?
The price is usually part of the facility's procedure or hospital supply charges and varies by supplier, contract, and location. Patients should ask the hospital or insurer about their specific out-of-pocket responsibility.