Maquet Cardiovascular has obtained the US Food and Drug Administration (FDA) approval and CE mark certification for a new size of intra-aortic balloon (IAB) catheter, designed for patients with left ventricular failure and other cardiac conditions.
The new Sensation Plus 7.5Fr. 40Cc catheter, which comes with two Statlock IAB stabilisation devices, is designed to improve hemodynamic support in patients who are 5ft to 5ft 4in tall (152cm – 162 cm).
The larger-volume IAB catheter uses the company’s IAB fiber-optic technology to displace more blood in the aorta during diastole, resulting in improved diastolic augmentation and systolic unloading.
Maquet Cardiovascular president and CEO Christian Keller said the company is committed to developing new products that continuously improve the therapy needs of hemodynamically compromised patients.
"Over the last 12 months, Maquer has launched two new families of IAB catheters, as well as a new balloon pump, Cardiosave – all of which are designed to revolutionise counterpulsation therapy, from both an efficacy and safety perspective," Keller said.
In addition to Sensation Plus 7.5Fr. 40Cc, the new products include Sensation Plus 8 Fr. 50cc catheter and Mega IAB catheters, available in 30cc, 40cc and 50cc sizes to improve hemodynamic support in patients of any height.
The Sensation Plus IAB catheters automatically calibrate in the patient after insertion and automatically recalibrate in vivo every two hours or sooner if patient or environmental conditions change, according to the company.