510(k), CE mark for Air-Band catheter device

MAQUET Cardiovascular LLC said it 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.

"We have found that Air-Band is easy to use, reliable and effective in achieving hemostasis following radially accessed coronary catheterization procedures," said Christian Valina, M.D., interventional cardiologist at the University Heart Centre of Bad Krozingen in Germany. "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." Similar positive feedback has also been received from other sites in the EU and USA.

"Drawing on our significant experience in hemostasis management, we designed Air-Band to provide all the valued benefits of our Safeguard Pressure Assisted Device—which assists in obtaining and maintaining hemostasis after a femoral procedure—and applied our knowledge to a radial application," said Christian Keller , president and chief executive officer of MAQUET Cardiovascular. "Both devices simplify hemostasis management by delivering hands-free adjustable pressure, offering simple application and removal, and providing clear site visibility and assessment without compromising patient comfort, which is a priority for us."

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.

Its textile wristband contributes to patient comfort, as it neither cuts into the skin nor has protruding plastic parts. The adhesive enablAir Jordan XXXI 31 Shoes