Maquet receives FDA 510(k) clearance and CE mark approval for its new Sensation Plus 7.5F 40cc intra-aortic balloon catheter


On 29 October 2012, Maquet Cardiovascular announced that it has received 510(k) clearance from the FDA and CE mark approval for its new Sensation Plus 7.5F 40cc intra-aortic balloon catheter. This new larger-volume, fibre-optic intra-aortic balloon catheter will allow clinicians to provide a higher-efficacy, faster intra-aortic balloon counterpulsation therapy to smaller patients – those who are 5’0” to 5’4” tall (152–162cm). It will be available for sale in the United States and in the European Union in October.

“Over the last 12 months, Maquet has launched two new families of intra-aortic balloon 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,” said Christian Keller, president and CEO of Maquet Cardiovascular. “As a global leader in haemodynamic support, we are dedicated to developing and marketing new and innovative products that continuously improve the therapy needs of haemodynamically compromised patients thereby improving patient outcomes.”

Since October 2011, Maquet has added new sizes to its higher efficacy intra-aortic balloon product lines to improve the delivery of hemodynamic support to the most critically ill patients. In addition to the Sensation Plus 8F 50cc catheter, Maquet has launched the Sensation Plus 7.5F 40cc intra-aortic balloon for patients 5’0” to 5’4” (152–162cm). Earlier this year, the company introduced its new Mega intra-aortic balloon catheters, a family of larger volume catheters (30cc, 40cc and 50cc) that allow clinicians to provide a significant increase in haemodynamic support to patients at any height. In 2012, Maquet also launched Cardiosave, the company’s new fibre-optic intra-aortic balloon pump designed with a large state-of-the-art touchscreen display and is smaller, lighter and quieter than any pump the company has ever offered.

Sensation Plus intra-aortic balloon catheters are a technological first in improved haemodynamic support, offering all of the benefits of Maquet’s easy-to-use intra-aortic balloon fibre-optic technology with the increased clinical effectiveness that larger volume intra-aortic balloons offer. Larger volume balloons displace more blood in the aorta during diastole, resulting in improved diastolic augmentation and systolic unloading.

The Sensation Plus intra-aortic balloon catheters automatically calibrate in the patient after insertion and automatically recalibrate in vivo every two hours or sooner if patient or environmental conditions change. The result is faster time to therapy, ongoing consistency and accuracy of the arterial blood pressure waveform, and improved ease-of-use.

Like Maquet’s Mega intra-aortic balloon catheters, the Sensation Plus intra-aortic balloon catheters come with two Statlock intra-aortic balloon Stabilization Devices, which allow the catheter to be secured to the patient’s leg without sutures. This is more comfortable for the patient and eliminates the risk of suture needle sticks for the clinician when initiating counterpulsation support.