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Maquet Cardiovascular LLC Receives FDA 510(k) Clearance for New Mega® Intra-Aortic Balloon Catheter Sizes


5/14/2012 7:13:42 AM

MAHWAH, N.J., May 14, 2012 /PRNewswire/ -- MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new MEGA 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters. These new, larger volume catheters will allow clinicians to provide patients with greater hemodynamic support, regardless of their height.

"The MEGA family of catheters represents a true advancement in IAB therapy and broadens our therapeutic offerings for clinicians and patients, as these new catheters deliver a significant increase in hemodynamic support regardless of the patient's height," said Christian Keller, President and CEO of MAQUET Cardiovascular. "As a global leader in hemodynamic support, MAQUET is committed to advancing IAB therapy, and we are confident that our larger volume balloons will remain the gold standard for clinicians when such support is needed."

The advanced design of the MEGA IAB family provides exceptional benefits for patients and clinicians. Larger volume balloons like MEGA displace more blood in the aorta during diastole, resulting in improved augmentation and unloading. Due to the unique balloon wrap, MEGA IABs have no step-down between the balloon membrane and the catheter shaft, which potentially decreases bleeding when using a sheathless approach. The new MEGA IABs also provide a patented, more durable Durathane balloon membrane and a co-lumen catheter design with a large 0.027 inch inner lumen for a reliable pressure transducer signal.

Additionally, all MEGA IABs come with two STATLOCK® IAB Stabilization Devices[1], which allow the catheter to be secured to the patient's leg without sutures. STATLOCK® provides safety and comfort for the patient and eliminates the risk of suture needle sticks for the clinician.

"We are constantly striving to provide our customers with new solutions that will improve clinical practice and patient outcomes," said Raoul Quintero, President and CEO of MAQUET Medical Systems USA, the distributer of MAQUET's IAB therapy products. "These new MEGA balloons round out our product offering and provide clinicians the ability to enhance hemodynamic support and patient care in a efficacious, safe and cost effective manner, regardless of patient size."

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.

The new IAB catheters will be available in May 2012. For more information about the MEGA IAB family, please visit http://ca.maquet.com.

About MAQUET

As a trusted partner for hospitals and clinicians since 1838, Maquet is a global leader in medical systems that advance surgical interventions, cardiovascular procedures and critical care. Maquet develops and designs innovative products and therapeutic applications for the operating room, hybrid OR/Cath lab, intensive care unit and patient transport within acute care hospitals, improving outcomes and quality of life for patients.

Cardiovascular specialties include intra-aortic balloon counterpulsation therapy for cardiac assist; coronary artery bypass surgery; aortic and peripheral vascular surgery; and extracorporeal circulation.

The Critical Care portfolio includes market-leading intensive care ventilators and anesthesia machines.

Maquet also equips Surgical Workplaces with critical infrastructure such as flexible room design for OR and ICU; OR tables; lights and ceiling supply units; and OR integration for image data management.

Maquet is a subsidiary of the publicly listed Swedish Getinge Group. In 2011, Maquet generated nearly 1.4 billion Euro which is more than half of the Group's annual revenue of 2.4 billion Euros. The Getinge Group has 13,000 employees worldwide, including around 6,000 Maquet 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 and www.getingegroup.com.

MAQUET The Gold Standard
www.maquet.com
www.getinge.com

[1] STATLOCK is a registered trademark of C.R. Bard Inc.

SOURCE MAQUET Cardiovascular



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