FDA and EU approve Sensation Plus (Maquet Cardiovascular) for patients with Heart Failure

Maquet Cardiovascular has received 510(k) clearance from the FDA and CE mark approval in the EU for its new Sensation Plus 40cc intra-aortic balloon (IAB) catheter. IAB therapy is used in patients with left ventricular failure and other cardiac conditions to augment coronary blood flow and to increase myocardial oxygen supply and decrease myocardial oxygen demand. This new larger-volume, fiber-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy to smaller patients � those who are 5'0" to 5'4" tall (152-162 cm). It will be available for sale in the US and in the EU in October.