Maquet's intra-aortic balloon catheter nets regulatory approval

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Maquet Cardiovascular has received both 510(k) clearance from the FDA and CE mark approval from the British Standards Institution for its new Sensation Plus 50cc 8 French intra-aortic balloon catheter, which combines fiber optic signal acquisition with hemodynamic support.

The new catheter also comes with two Stat Lock IAB stabilization devices which allow the catheter to be secured to the patient's leg without sutures, according to the Mahwah, N.J.-based company. The product will be available for sale in October.

Intra-aortic balloon counterpulsation is an adjunct therapy that is used in patients with left ventricular failure and other cardiac conditions.