Maquet Cardiovascular has received a CE Mark approval for its Mega 8Fr. 50cc intra-aortic balloon (IAB) catheter.
With an 8Fr. shaft, the Mega has a smaller insertion point than traditional 50cc IABs and offers blood volume displacement for intra-aortic balloon counterpulsation, Maquet said. The design has a Durathane blow-molded balloon membrane, a full-length polyimide lumen with no gas lumen insert and safety features such as a handle protector to keep the membrane wrapped prior to use.
The Mega will be available for distribution in CE countries in October, according to the Fairfield, N.J.-based company.