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Maquet Quadrox-iD oxygenator gets FDA marketing approval |
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Friday, 18 June 2010 |
Maquet Cardiovascular has received FDA 510 (k) marketing clearance for its Quadrox-iD pediatric diffusion membrane oxygenator for use in an extracorporeal perfusion system for pediatric patients up to six hours. Maquet claimed that the Quadrox-iD pediatric oxygenator is yet another milestone in company's ongoing commitment to the perfusion community and cardiac surgical team. It is currently conducting a limited commercial launch of the Quadrox-iD pediatric oxygenator in the U.S. and intends to implement a comprehensive launch in the third quarter of 2010. Raoul Quintero, President and CEO of Maquet Cardiovascular's U.S. sales unit, said: "The approval of the first-in-class Quadrox-iD Pediatric Oxygenator sets the standard for the perfusion of children and is another example of Maquet's dedication to innovation and improving extracorporeal procedures and outcomes for physicians and patients”.
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