Maquet lands FDA nod for Air-Band catheter device

April 11, 2013 by Brad Perriello

The FDA grants 510(k) clearance for Maquet Cardiovascular's Air-Band radial compression device, used to help close incisions to the radial artery to introduce catheters.

Maquet Cardiovascular

Getinge (PINK:GETI B) subsidiary Maquet Cardiovascular racked up a win for another of its devices designed to close artery incisions for catheters after the FDA cleared its Air-Band radial compression device for the U.S. market.

The device is designed to help seal the radial artery after a catheterization procedure, in which the catheter is threaded into the heart via a radial artery incision in the wrist.

"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," Maquet Cardiovascular president & CEO Christian Keller said in prepared remarks. "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."

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Last month Maquet won 510(k) clearance and CE Mark approval in the European Union for a new, larger-volume version of its Sensation Plus intra-aortic balloon catheter.