FDA 510(k) And CE Mark For Maquet’s New SENSATION PLUS® 7.5Fr 40cc Intra-Aortic Balloon Catheter

In short

Maquet Cardiovascular LLC, has received 510(k) clearance from the U.S. FDA and CE mark approval for its new Sensation Plus® 7.5Fr. 40cc intra-aortic balloon (IAB) catheter.

The company says this new larger-volume, fibre-optic IAB catheter will allow clinicians to provide a higher-efficacy IAB counterpulsation therapy “at the speed of light” to smaller patients those who are 5’0″ to 5’4″ tall (152-162 cm). It will be available for sale in the United States and in the EU in October.

Background

IAB counterpulsation is an adjunctive therapy that is often used in patients with left ventricular failure and other cardiac conditions. When the IAB is inserted into the patient’s aorta and counterpulsates with the heart, it augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand. Maquet has a very good video clip on its site, here.  which provides an insight into the significance of appropriate device sizing for the patient’s anatomy.

Since October 2011, Maquet 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 Sensation Plus 8 Fr. 50cc catheter, the company has now launched the 7.5Fr 40cc iteration for patients 5’0″ to 5’4″ (152-162 cm).

Maquet says its Sensation Plus IAB catheters are a technological first in improved hemodynamic support, offering all of the benefits of its easy-to-use IAB fiber-optic technology with the increased clinical effectiveness that larger volume IABs offer. Larger volume balloons displace more blood in the aorta during diastole, resulting in claimed improved diastolic augmentation and systolic unloading.

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. The result is faster time to therapy, ongoing consistency and accuracy of the arterial blood pressure waveform, and improved ease-of-use.

The Sensation Plus IAB catheters come with two Statlock® IAB 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.

Company comments

“Over the last 12 months, Maquet 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,” said Christian Keller, President and CEO of Maquet Cardiovascular. “As a global leader in hemodynamic support, we are dedicated to developing and marketing new and innovative products that continuously improve the therapy needs of hemodynamically compromised patients thereby improving patient outcomes.”

Source: Maquet Cardiovascular LLC, PR Newswire

*Statlock is a registered trademark of C.R. Bard Inc.