New Mega Intra-Aortic Balloon Catheter Sizes From Maquet


May 16, 2012

Maquet Cardiovascular LLC announced it 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 in May 2012. The larger volume catheters will allow clinicians to provide patients with greater hemodynamic support, regardless of their height.

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.

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 became available May 2012.

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