Maquet Cardiovascular LLC Receives FDA 510(k) Clearance and CE Mark Approval for AIR-BAND Radial Compression Device
4/11/2013 6:50:11 AM
WAYNE, N.J., April 11, 2013 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and European CE mark approval for its new AIR-BANDRadial 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 Devicewhich assists in obtaining and maintaining hemostasis after a femoral procedureand 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.
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.
MAQUET, a trusted partner for hospitals and physicians for over 175 years, is the global leader in providing medical systems that meet the needs of the most medically challenging patients, while exceeding the expectations of the hospital teams that care for them. MAQUET designs, develops and distributes innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital including the operating room (OR), hybrid OR/cath lab and intensive care unit (ICU) as well as intra and inter hospital patient transport.
Headquartered in Rastatt, Germany, MAQUET is the largest subsidiary of the publicly listed Getinge Group AB of Sweden. MAQUET generated about 1.5 billion Euros in 2012, representing more than half of the Getinge Group's annual revenue of 2.7 billion Euros. MAQUET has 6,300 employees in 45 international sales and service organizations, as well as a network of more than 300 sales representatives. For more information please visit www.maquet.com.
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SOURCE MAQUET Cardiovascular LLC