MAQUET Cardiovascular Receives 510(k) Marketing Clearance for QUADROX-iD Pediatric Diffusion Membrane Oxygenator
WAYNE, N.J., June 2 /PRNewswire/ -- MAQUET Cardiovascular LLC today announced that its QUADROX-iD Pediatric Diffusion Membrane Oxygenator received 510(k) marketing clearance from the U.S. Food and Drug Administration for use in an extracorporeal perfusion system for pediatric patients up to six hours.
"The QUADROX-iD Pediatric Oxygenator provides a long-awaited membrane lung specifically for infants and children," said Robert H. Bartlett, M.D., professor emeritus of surgery at the University of Michigan. "The small size of this pediatric oxygenator, coupled with its low pressure drop and biocompatible coating, will contribute to improving outcomes for pediatric patients."
The QUADROX-iD Pediatric Oxygenator is yet another milestone in MAQUET's ongoing commitment to the perfusion community and cardiac surgical team. It has several features that differentiate it from existing pediatric oxygenators and result in improved clinical benefit. These include small size, high performance and safe handling, which allow for the precise management of extracorporeal perfusion in children, a patient population for whom there is little room for error. Specifically:
- It is the first commercially available pediatric oxygenator to incorporate an advanced polymethylpentene (PMP) hollow-fiber membrane technology, which is designed to eliminate plasma leaks and prevent the formation of micro-bubbles. Eliminating plasma leaks prevents unnecessary circuit changes, which often lead to blood transfusions.
- It is smaller in size than other PMP oxygenators, which can be twice the size of an infant patient. As a result, it may eliminate the need for blood transfusions and their associated complications.
- It has high gas transfer rates which provide reserves for even bigger children and a very high volume efficiency index compared to other pediatric oxygenators which cover a similar blood flow range.(1) Within the specified flow rate range (0.2-2.8 liters/minute), it oxygenates the blood, removes carbon dioxide and regulates the blood temperature for up to six hours.
- It incorporates MAQUET's BIOLINE Coating to a biocompatible surface. The hematologic benefits of a biocompatible surface include preserved platelet function, reduced clotting and thrombus formation, and decreased activation of the complement system of the immune system.
- It requires a low priming volume of 81 ml, and its well-established de-airing membrane makes the priming procedure quick, easy, and safe.
"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," said Raoul Quintero, president and chief executive officer of MAQUET Cardiovascular's U.S. sales unit. "MAQUET continues to invest in and advance the science of perfusion, and we are pleased to be the first company to deliver the beneficial PMP membrane technology for use in the pediatric population. 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."
MAQUET is currently conducting a limited commercial launch of the QUADROX-iD Pediatric Oxygenator in the United States and intends to implement a comprehensive launch in the third quarter of this year.
About MAQUET Cardiovascular
MAQUET Cardiovascular was formed in 2003 and is a leader in providing innovative products for cardiac surgery, vascular intervention and cardiac support to hospitals and clinics and the cardiac surgeons, interventional cardiologists, perfusionists and other healthcare professionals who care for patients with cardiovascular disease. MAQUET Cardiovascular is focused on providing clinicians with future-oriented technology that fits into their daily practice and improves the therapeutic management of patients. MAQUET Cardiovascular continues to invest in the development of innovative technologies and solutions that advance clinical practice, improve patient outcomes and enhance quality of life.
MAQUET Cardiovascular provides healthcare professionals with products in four business units: Cardiopulmonary (perfusion products), Cardiac Surgery (clampless beating heart and endoscopic vessel harvesting), Vascular Interventions (grafts for vascular surgery), and Cardiac Assist (intra-aortic balloon counterpulsation therapy).
About The MAQUET Group
The MAQUET Group is the global market leader for Medical Systems, focusing on the Operating Room (OR), Cath Lab, Intensive Care Unit (ICU) and Patient Transport. The integrated products of MAQUET are specially designed to deliver optimal clinical treatment and therapeutic applications within acute care hospitals. MAQUET provides innovative medical solutions from three Divisions:
- Cardiovascular with products for cardiac assist (intra-aortic balloon counterpulsation therapy), coronary artery bypass surgery, complex aortic surgery reconstruction, peripheral interventions and extracorporeal circulation.
- Critical Care for intensive care ventilators and anesthesia machines.
- Surgical Workplaces for OR tables, lights and ceiling service units, flexible room design for OR, Cath Lab and ICU as well as digital OR integration.
MAQUET is a subsidiary of the publicly-listed Swedish GETINGE GROUP, a company with around $3 billion in revenues (2009 fiscal year) and 12,100 employees worldwide. In 2009 MAQUET itself generated revenues of around $1.5 billion. The company now has more than 5,000 employees in 36 international sales and service organizations, as well as a network of more than 250 sales representatives. Twelve manufacturing sites are located in 6 countries.
MAQUET The Gold Standard.
(1) Data on File. Volume Efficiency Index: Ratio of max. blood flow rate (ml/min) to static priming volume (ml)
SOURCE MAQUET Cardiovascular LLC