FDA 510(k) Clearance for Maquet’s New Mega® Intra-Aortic Balloon Catheter Sizes

In short

MAQUET Cardiovascular LLC 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.

Background

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.

According to a press release, the advanced design of the MEGA IAB family provides exceptional benefits for patients and clinicians. 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 Maquet tells us that 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.

Maquet’s parent company Getinge last year announced its acquisition of Atrium Medical as announced on our pages. The company clearly has big ambitions in interventional cardiology.

Company comments

“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.”

“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, the distributer 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.”

Availability

The new IAB catheters will be available in May 2012.

Source: Maquet, PR Newswire