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."
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.
