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.
Maquet is currently conducting a limited commercial launch of the Quadrox-iD Pediatric Oxygenator in the US and intends to implement a comprehensive launch in the third quarter of the current year.
Raoul Quintero, president and CEO of Maquet Cardiovascular’s US 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.
“During the H1N1 influenza pandemic, PMP oxygenators were recommended in the clinical practice guidelines of the Extracorporeal Life Support Organization. We believe that the use of a Quadrox-iD Pediatric oxygenator in an extracorporeal perfusion system will satisfy an urgent need in pediatric centers worldwide.”