The US Food and Drug Administration (FDA) has granted 510(k) clearance for Maquet Cardiovascular's new Mega 7.5Fr. 30cc and 40cc intra-aortic balloon (IAB) catheters.
The new, larger volume IAB catheters will displace more blood in the aorta during diastole, resulting in improved augmentation and unloading, and will also enable clinicians to provide patients with greater hemodynamic support, regardless of their height.
The Mega IAB catheters also offer 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.
Due to the unique balloon wrap, Mega IABs have no step-down between the balloon membrane and the catheter shaft, which results in decreased bleeding when using a sheathless approach.
The Mega IABs incorporate two Statlock IAB stabilisation devices, which allow the catheter to be secured to the patient's leg without sutures.
Maquet Cardiovascular president and CEO Christian Keller said the Mega family of catheters broadens the company's therapeutic offerings for clinicians and patients, as the new catheters deliver a considerable increase in hemodynamic support regardless of the patient's height.
Maquet's medical systems US president and CEO Raoul Quintero said: "These new Mega balloons round-out our product offering and provide clinicians with the ability to enhance hemodynamic support and patient care in an efficacious, safe and cost effective manner, regardless of patient size."
Maquet develops and designs products and therapeutic applications for performing surgical interventions, cardiovascular procedures and critical care across the operating room, hybrid OR/cath lab and intensive care unit.
Image: The new Mega 7.5Fr. 30cc and 40cc intra-aortic balloon catheters have been approved by the FDA. Photo courtesy of: Maquet Cardiovascular.