Maquet earns FDA thumbs up for intra-aortic balloon catheter
The FDA has cleared the Maquet Cardiovascular Mega 8Fr. 50cc intra-aortic balloon (IAB) catheter, which the company said offers additional blood volume displacement for intra-aortic balloon counterpulsation.
Mega, compared to 40cc IABs, delivers 25 percent more blood volume displacement, according to the Fairfield, N.J.-based Maquet. The company said additional features include a Durathane blow-molded balloon membrane, a full-length polyimide lumen with no gas lumen insert and safety features, such as a T-handle protector to keep the membrane tightly wrapped prior to use.
Mega, compared to 40cc IABs, delivers 25 percent more blood volume displacement, according to the Fairfield, N.J.-based Maquet. The company said additional features include a Durathane blow-molded balloon membrane, a full-length polyimide lumen with no gas lumen insert and safety features, such as a T-handle protector to keep the membrane tightly wrapped prior to use.