FDA 510(k) clearance and CE mark for AIR- BAND radial compression device

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Maquet has announced that it has received 510(k) clearance from the FDA and European CE mark approval for its new AIR-BAND radial compression device, which is indicated to assist haemostasis of the radial artery after a transradial procedure.

According to a company press release, the device is designed to compress the radial artery puncture site while maintaining site visibility and a secure fit around the wrist.


Christian Valina, interventional cardiologist at the University Heart Centre of Bad Krozingen in Germany, said: “We have found that AIR-BAND is easy to use, reliable and effective in achieving haemostasis following radially accessed coronary catheterization procedures. My colleagues and I were impressed by the secure fit around the wrist that the adhesive band provides. We believe that AIR-BAND represents important progress towards ensuring patient safety and comfort during these important procedures.”  

 

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