Maquet receives FDA clearance for Mega, the world’s first 8F 50cc intra-aortic balloon catheter


Maquet Cardiovascular announced on 22 September at the Transcatheter Cardiovascular Therapeutics (TCT) convention in San Francisco, US, that the FDA has cleared the company’s Mega 8F 50cc intra-aortic balloon catheter.

As the world’s first 50cc intra-aortic balloon with a true 8F shaft, the Mega has a smaller insertion point than traditional 50cc intra-aortic balloons and offers additional blood volume displacement for intra-aortic balloon counterpulsation. Mega, compared to 40cc intra-aortic balloons, delivers 25% more blood volume displacement and provides improved unloading and augmentation. The Mega will be available for distribution in September 2009.

Mega balloon’s impact in patient care was recently noted in the clinical setting. “I recently admitted a critically ill, approximately 400-pound patient and inserted the Mega 50cc balloon,” said George W Christy, interventional cardiologist with Advocate Christ Medical Center’s Transplant and Assist Device team in Oak Lawn, US. “The increased augmentation we observed from Mega allowed us to stabilise the patient.” Christy believes that “the Mega gave us the needed window of time to consider further alternatives to manage this patient.”

Maquet Cardiovascular recently acquired Datascope, a distinguished provider of gold-standard intra-aortic balloons and cardiac assist products. By uniting forces, Maquet is even better positioned to advance patient care technology through innovations like the Mega.

Since the Mega has no step down between the catheter shaft and the balloon material, it may be inserted sheathless or through an 8F sheath. Because of its unique design, it can benefit patients presently using both 50cc and 40cc intra-aortic balloons. Additional benefits include a unique Durathane blow-molded balloon membrane, a full-length polyimide lumen with no gas lumen insert, and numerous safety features, such as a T-handle protector to keep the membrane tightly wrapped prior to use.

Intra-aortic balloon counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the intra-aortic balloon inserted into the patient’s aorta counterpulsates with the heart, it augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand.

“Since the MEGA is indicated for patients 5’4” and taller, I would generally use it as my standard balloon moving forward,” said Christy. “It is straightforward, easy to insert, and compatible with all the standard consoles.”