Maquet Cardiovascular US Sales LLC, based in Wayne, N.J., has received 510(k) clearance from the U.S. Food and Drug Administration for its Mega 7.5 Fr 30cc and 40 cc intra-aortic balloon (IAB) catheters. According to the company, these new larger-volume catheters will allow clinicians to provide patients with greater hemodynamic (blood flow and circulation measurement) support, regardless of their height. The new sizes also will facilitate displacing more blood in the aorta during diastole (the period when the heart is refilling with blood after a contraction).
The IABs are designed with no step-down between the balloon membrane and the catheter shaft, a feature which may decrease bleeding during a sheathless approach, the company claims. The new IABs are made of a durathane membrane, which reportedly is stronger than conventional balloon membrane material, polyethylene terephthalate (also known as PET, the substance from which soda bottles are made) or nylon. Durathane is a polymer patented by AngioDynamics. The catheter also has a co-lumen design with a large 0.027-inch inner lumen for a more reliable pressure transducer signal.
All Mega IABs also come with two Statloack IAB stabilization devices, which allow the catheter to be secured to patients’ legs without sutures.
IAB counterpulsation is an adjunctive therapy 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.
Maquet develops and designs a variety of operating room products. Cardiovascular specialties include intra-aortic balloon counterpulsation therapy for cardiac assist; coronary artery bypass surgery; aortic and peripheral vascular surgery; and extracorporeal circulation. Maquet is a subsidiary of the Getinge Group, based in Sweden. Maquet Cardiovascular is a division of Maquet Medical Systems.
IAB Catheter Size Offering Expanded by Maquet
Published June 11, 2012
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