Maquet Cardiovascular has received both 510(k) clearance from the US FDA and CE mark approval from the British Standards Institution (BSi) for its new Sensation Plus 50cc 8 Fr. intra-aortic balloon catheter. This is the first catheter combining fiber optic signal acquisition with greater haemodynamic support compared to a standard 40cc intra-aortic balloon catheter.
Sensation Plus provides 25% more blood volume displacement than standard 40cc intra-aortic balloon catheters, allowing for improved unloading and better augmentation. This new catheter also comes with two Stat Lock intra-aortic balloon stabilisation devices which allow the catheter to be secured to the patient’s leg without sutures. This is more comfortable for patients and eliminates the risk of suture needle sticks for clinicians when initiating counterpulsation support.
“Clinicians have been asking for an intra-aortic balloon catheter that combines all of the benefits of fiber optic technology; faster initiation of therapy, easier patient management and a crisp, clean arterial pressure wave form with increased haemodynamic support,” said Deb Joseph, vice president, Marketing and Clinical Services. “We believe that the new, state-of-the art Sensation Plus intra-aortic balloon catheter meets these needs and will enable clinicians to provide patients with improved care.”
This catheter will be available for sale in October.