MAQUET Cardiovascular Receives FDA 510(k) Clearance For New Mega® Intra-Aortic Balloon Catheter Sizes
MAHWAH, N.J., May 14, 2012 — MAQUET Cardiovascular LLC 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.
Larger volume balloons like Mega displace more blood in the aorta during diastole, resulting in improved augmentation and unloading. Due to the 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.
The new IAB catheters will be available in May 2012. For more information about the Mega IAB family, please visit http://ca.maquet.com.
[1] Statlock is a registered trademark of C.R. Bard Inc.
