CardiacAssist Receives FDA 510(k) Clearance For Its TandemLung Oxygenator

TandemLung is the newest addition to an expanding portfolio of medical devices offered by the manufacturer of the world's first percutaneous circulatory support platform

Mar 15, 2016, 09:00 ET from CardiacAssist, Inc.

PITTSBURGH, March 15, 2016 /PRNewswire/ -- CardiacAssist, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new TandemLung® oxygenator, a medical device that acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood.  When paired with CardiacAssist's TandemHeart® blood pump, the TandemLung represents a leap forward in extracorporeal life support (ECLS) technology for patients in need of critical cardiopulmonary care.

Every year in North America, more than 300,000 patients experience an acute cardiac or respiratory event that requires emergency intervention.  However, historically only a small percentage of these patients have received advanced life support utilizing products like the TandemHeart and TandemLung, primarily due to the complexity of deploying existing technology to perform such procedures.  The TandemLung oxygenator was developed to make ECLS faster and more accessible with a design optimized for simplicity and performance.  Its low priming volume and patent-protected radial flow technology allow the device to be deployed quickly to protect patients from the negative effects of diminished cardiac or respiratory function.

"After our original TandemHeart pump was cleared for use with an oxygenator in 2011, our team immediately began working with experts in the field to understand how to reduce the complexity of cardiopulmonary bypass technology so that more patients could receive this potentially life-saving procedure," said John Marous, President and CEO of CardiacAssist.  "The design of the TandemLung is a direct result of those efforts.  This release represents our 6th new product clearance since September 2013, and we are proud to dedicate ourselves to improving the lives of patients by delivering innovative, easy-to-use devices for simplified life support."

Adult ECLS has grown from less than 100 procedures per year in the 1990's to more than 3,000 procedures per year in 20151, and today it comprises the most rapidly growing segment of the circulatory support industry.  Healthcare professionals and hospitals can now turn to CardiacAssist as a premier, single-source provider of a comprehensive circulatory support platform including the TandemHeart, TandemLung, and the ProtekDuo and ProtekSolo lines of cannulae.

About TandemLung

The TandemLung utilizes a patent-protected and optimized radial flow design coupled with advanced polymethylpentene (PMP) fibers to transfer oxygen into the blood for patients requiring cardiac or respiratory support.  It is intended for use in adult patients for extracorporeal circulation during cardiopulmonary bypass for up to 6 hours.

About CardiacAssist

CardiacAssist is a growing, privately-held medical device company headquartered in Pittsburgh, Pennsylvania, that developed the world's first FDA-cleared and CE-marked short-term extracorporeal circulatory support platform.  The TandemHeart system has provided critical cardiopulmonary support to thousands of patients in the top hospitals worldwide.

1 Extracorporeal Life Support Organization (ELSO).  ECLS Registry Report: United States Summary.  January 2015.

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SOURCE CardiacAssist, Inc.



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