Maquet Cardiovascular receives FDA 510(k) clearance for new Mega Intra-Aortic Balloon Catheter sizes


Maquet Cardiovascular has announced that it has received FDA 510(k) clearance 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 haemodynamic 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 haemodynamic support regardless of the patient’s height,” said Christian Keller, president and CEO, Maquet Cardiovascular.

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 stabilisation devices (Bard), which allow the catheter to be secured to the patient’s leg without sutures.