Maquet Air-Band Radial Compression Device Receives FDA 510(k) Clearance, CE Mark

Device to assist hemostasis of the radial artery after a transradial procedure


April 16, 2013

Maquet Cardiovascular LLC has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European CE mark approval for its new Air-Band Radial Compression Device. Indicated to assist hemostasis of the radial artery after a transradial procedure, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist. Air-Band will be commercially available in the European Union later this month and in the United States in April.

Air-Band is a 26-cm long, latex-free, self-adhesive wristband with a clear window and bulb that facilitate visualization of the puncture site. A luer valve on the end of the clear fill tube enables any standard syringe to be connected to inflate and deflate the bulb with air to provide compression of the radial puncture site.

With its textile wristband, Air-Band contributes to patient comfort, as it neither cuts into the skin nor has protruding plastic parts. The adhesive enables a secure fit around all patient wrists, avoiding movement and dislocation. Both the size and shape of Air-Band’s inflatable bulb minimize the compression risk to surrounding nerve structures or areas other than the radial puncture site. The standard luer valve allows easy inflation and deflation with any standard luer syringe.

The device received clearance in April 2013.

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