MAQUET Cardiovascular Receives FDA Clearance For MEGA(TM), The World's First 8Fr. 50cc Intra-Aortic Balloon Catheter

Main Category: Cardiovascular / Cardiology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Sep 2009 - 2:00 PDT

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MAQUET Cardiovascular LLC, a leading provider of cardiovascular technologies, announced today at the Transcatheter Cardiovascular Therapeutics (TCT) convention in San Francisco, Calif., that the U.S. Food and Drug Administration has cleared the company's MEGA(TM) 8Fr. 50cc intra-aortic balloon (IAB) catheter. As the world's first 50cc IAB with a true 8Fr. shaft, the MEGA has a smaller insertion point than traditional 50cc IABs and offers additional blood volume displacement for intra-aortic balloon counterpulsation. MEGA, compared to 40cc IABs, delivers 25 percent 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," stated George W. Christy, M.D., FACC, Interventional Cardiologist with Advocate Christ Medical Center's Transplant and Assist Device team in Oak Lawn, Ill. "The increased augmentation we observed from MEGA allowed us to stabilize the patient." Dr. Christy believes that "the MEGA gave us the needed window of time to consider further alternatives to manage this patient."

"The MEGA truly demonstrates MAQUET's firm commitment to improving patient outcomes," says Christian Keller, President of MAQUET Cardiovascular. "For some time now, physicians have been seeking increased hemodynamic support with IAB therapy. The MEGA 8Fr. 50cc meets this need while providing a smaller shaft size, setting a new standard in IAB technology."

MAQUET Cardiovascular recently acquired Datascope, a distinguished provider of gold-standard IABs 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 8 Fr. sheath. Because of its unique design, it can benefit patients presently using both 50cc and 40cc IABs. 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.

"We've designed the MEGA to provide outstanding performance for a wider range of patients while reducing the risk for vascular complications," added Keller. "At the same time, we've made it very easy to use for physicians, and we're confident that they'll find it to be a true advance in IAB therapy."

Intra-aortic balloon counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the IAB 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 Dr. Christy. "It's straightforward, easy to insert, and compatible with all the standard consoles."

INFORMATION ABOUT THE MAQUET GROUP

The MAQUET Group is the global market leader for Medical Systems, focusing on the Operating Room (OR) and Intensive Care Unit (ICU). The integrated products of MAQUET are specially designed to deliver optimal clinical treatment and therapy concepts within acute care hospitals. MAQUET provides innovative medical solutions from three Divisions:

-- Cardiovascular with products for cardiac assist (intra-aortic balloon counterpulsation therapy), coronary artery bypass surgery, heart valve repair, aneurysm and vascular repair, peripheral interventions and extracorporeal circulation.

-- Critical Care for intensive care ventilators and anesthesia machines

-- Surgical Workplaces for OR tables, lights and ceiling service units, prefabricated OR and ICU suites as well as telemedicine for the OR integration.

MAQUET is a subsidiary of the publicly-listed Swedish group of companies GETINGE AB, a company with over $2.8 billion in revenues (2008 fiscal year) and 12,800 employees worldwide. In 2008 MAQUET itself generated pro-forma revenues (including the acquisition of Datascope Corp.) of over $1.4 billion. The company now has 5,000 employees in 34 international sales and service organizations, as well as a network of more than 200 sales representatives.

Source: MAQUET Cardiovascular

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