Maquet Receives FDA and CE Mark Approval for Sensation Plus 7.5-F, 40-cc IAB Catheter

October 29, 2012—Maquet Cardiovascular, LLC (Wayne, NJ) announced that it has received 510(k) clearance from the US Food and Drug Administration and CE mark approval for its Sensation Plus 7.5-F, 40-cc intra-aortic balloon (IAB) catheter.

According to Maquet, this new larger-volume, fiber-optic IAB catheter provides a higher-efficacy IAB counterpulsation therapy to smaller patients—those who are 5'0" to 5'4" tall (152-162 cm). The device will be available for sale in the United States and in the European Union in October.

Since October 2011, the company has added new sizes to its higher efficacy IAB product lines to improve the delivery of hemodynamic support to the most critically ill patients. In addition to the new Sensation Plus 7.5-F, 40-cc catheter, Maquet launched the Sensation Plus 8-F, 50-cc catheter; the Mega IAB family of larger volume catheters (30 cc, 40 cc, and 50cc); and the CardioSave fiber-optic IAB pump with a large touchscreen display.

In its press release, Maquet stated that Sensation Plus IAB catheters combine the ease-of-use benefits of fiber-optic technology with the increased clinical effectiveness of larger volume balloons, which displace more blood in the aorta during diastole, resulting in improved diastolic augmentation and systolic unloading. The Sensation Plus IAB catheters automatically calibrate in the patient after insertion and automatically recalibrate in vivo every 2 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.

Maquet noted that like its Mega IAB catheters, the Sensation Plus IAB catheters come with two StatLock IAB stabilization devices that allow the catheter to be secured to the patient's leg without sutures, which is more comfortable for the patient and eliminates the risk of suture needle sticks for the clinician when initiating counterpulsation support.