MAQUET Cardiovascular Announces U.S. Food and Drug Administration Panel Votes To Reclassify Intra-Aortic Balloon Pumps To A Class II Designation In Certain I... (. The FDA classifies medical device...)

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MAQUET Cardiovascular Announces U.S. Food and Drug Administration Panel Votes To Reclassify Intra-Aortic Balloon Pumps To A Class II Designation In Certain Indications

Date:12/13/2012

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.

About MAQUET

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
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