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March 15, 2016

FDA grants 510(k) clearance for CardiacAssist’s new TandemLung oxygenator

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardiacAssist's new medical device, the TandemLung oxygenator, which acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood.

CardiacAssist TandemLung

The US Food and Drug Administration (FDA) has granted 510(k) clearance for CardiacAssist’s new medical device, the TandemLung oxygenator, which acts as an artificial lung to infuse oxygen and remove carbon dioxide from the blood.

The device uses a patent-protected and optimised radial flow design, coupled with advanced polymethylpentene (PMP) fibres to transfer oxygen into the blood for patients requiring cardiac or respiratory support.

The TandemLung oxygenator is intended for use in adult patients for extracorporeal circulation during cardiopulmonary bypass for up to six hours.

“We are proud to dedicate ourselves to improving the lives of patients by delivering innovative, easy-to-use devices for simplified life support.”

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.

The low priming volume and patent-protected radial flow technology allows the device to be deployed rapidly to protect patients from the negative effects of diminished cardiac or respiratory function.

CardiacAssist president and CEO John Marous said: "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.

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"The design of the TandemLung is a direct result of those efforts. This release represents our sixth 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."

In North America, more than 300,000 patients a year experience an acute cardiac or respiratory event that requires emergency intervention.

CardiacAssist now offers healthcare professionals and hospitals with a circulatory support platform including the TandemHeart, TandemLung and the ProtekDuo and ProtekSolo lines of cannulae.


Image: CardiacAssist’s new TandemLung oxygenator. Photo: courtesy of CardiacAssist, Inc.

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