WAYNE, N.J., Dec. 13, 2012 /PRNewswire/ -- MAQUET Cardiovascular, the leader in intra-aortic balloon (IAB) therapy, today announced that the Circulatory System Devices Panel of the U.S. Food and Drug Administration (FDA) recently voted to support the Agency's reclassification of intra-aortic balloon pump (IABP) devices for certain indications to Class II (general controls and special controls) from Class III (general controls and pre-market approval). Those indications that received a recommendation to be reclassified to a Class II designation include acute coronary syndrome, complications of heart failure of both ischemic and non-ischemic etiologies, and cardiac and non-cardiac surgery.
According to the FDA and its panel of physicians and representatives, this recommendation was based on 40 years of extensive clinical experience and extensive literature, which support the hemodynamic effects and the devices' safety and effectiveness in the aforementioned patient populations.
"As the leaders in intra-aortic balloon (IAB) therapy, we are proud that the proven nature, tremendous volume of clinical evidence and clinical utility was validated by both the FDA and members of the panel and that IABPs have set the bar for other devices in this category," said Luca Lombardi, M.D., Chief Medical Officer, MAQUET Cardiovascular. "IAB therapy has been trusted by physicians for decades, and we believe this panel vote is a testament to the importance and utility of this treatment as the standard first-line therapy for patients requiring hemodynamic support."
"MAQUET applauds the FDA panel for recognizing the safety and efficacy of IAB therapy and its benefit for patients in need," said Raoul Quintero, President and CEO, MAQUET Medical Systems USA. "Securing Class II status for IABPs will enable us to rapidly bring new technologies to market so that physicians may continue to deliver the most advanced technology in hemodynamic support to their patients."
The FDA classifies medical devices using three designations, with Class III requiring the most stringent regulations—including premarket approval—for assuring the safety and effectiveness of devices. The Circulatory System Devices Panel provides the FDA with independent expert advice and recommendations; however, the final decision regarding Class designations is made by the FDA.
The panel, which met on December 5–6, 2012, in Gaithersburg, Md., also recommended that IABPs retain a Class III designation for the treatment of septic shock and intraoperative pulsatile flow generation, indications for which the devices are less commonly used.
MAQUET Medical Systems USA makes and distributes a variety of IAB catheters and pumps, including the SENSATION PLUS, MEGA, SENSATION and LINEAR product lines of IAB catheters, as well as the recently launched CARDIOSAVE IABP.
About IAB Counterpulsation Therapy
IAB counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the IAB is inserted into the patient's aorta and counterpulsates with the heart, it augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand. For more than 40 years, it has been the standard of care for critically ill patients who require hemodynamic support, with more than one million patients treated.
MAQUET, a trusted partner for hospitals and physicians for over 175 years, is the global leader in providing medical systems that meet the needs of the most medically challenging patients, while exceeding the expectations of the hospital teams that care for them. MAQUET designs, develops and distributes innovative therapy solutions and infrastructure capabilities for high-acuity areas within the hospital including the operating room (OR), hybrid OR/cath lab and intensive care unit (ICU) as well as intra and inter hospital patient transport.
Headquartered in Rastatt, Germany, MAQUET is the largest subsidiary of the publicly listed Getinge Group AB of Sweden. MAQUET generated nearly 1.4 billion Euros in 2011, representing more than half of the Getinge Group's annual revenue of 2.4 billion Euros. MAQUET has 6,000 employees in 50 international sales and service organizations, as well as a network of more than 280 sales representatives. For more information please visit www.maquet.com.
SOURCE MAQUET Cardiovascular