Maquet Receives FDA Clearance for New Mega Intra-Aortic Balloon Catheter Sizes


May 16, 2012

May 16, 2012 — Maquet Cardiovascular LLC announced this week that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Mega 7.5 Fr. 30 cc and 40 cc intra-aortic balloon (IAB) catheters. The 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."

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, 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, distributor 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 May 2012.

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