Technology | September 20, 2011

Maquet Receives FDA Clearance, CE Mark for Sensation Plus Intra-Aortic Balloon

September 20, 2011 — Maquet Cardiovascular announced it has received both 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Sensation Plus 50 cc 8 French intra-aortic balloon (IAB) catheter. The device also received CE mark approval from the British Standards Institution (BSI).

The new catheter incorporates fiber optic signal acquisition and provides 25 percent more blood volume displacement than standard 40cc IAB catheters, allowing for improved unloading and better augmentation. It also comes with two Stat Lock IAB stabilization devices that 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. 

Intra-aortic balloon counterpulsation is an adjunctive therapy often used in patients with left ventricular failure and other cardiac conditions. When the IAB, inserted into the patient's aorta, counterpulsates with the heart, it augments coronary blood flow to increase myocardial oxygen supply and decrease myocardial oxygen demand.

Sensation Plus will be available for sale in October 2011.

For more information: http://ca.maquet.com

Related Content

Getinge Issues Worldwide Voluntary Correction of Maquet/Getinge Cardiosave Intra-Aortic Balloon Pump
News | Intra-Aortic Balloon Pumps (IABP) | September 24, 2018
September 24, 2018 — Getinge is voluntarily initiating a worldwide recall involving a field correction of approximate
Maquet Datascope Corp. is recalling the CardioSave Hybrid Intra-aortic Balloon Pump (IABP).

The touchscreen Maquet Datascope CardioSave Hybrid Intra-aortic Balloon Pump (IABP) system console.

News | Intra-Aortic Balloon Pumps (IABP) | June 06, 2018
June 6, 2018 — Maquet Datascope Corp.
An example of an intra-aortic balloon pump (IABP) from Maquet. The results of the SEMPER FI trial. #europcr2018 #Europcr

An example of an intra-aortic balloon pump (IABP) from Maquet. 

Feature | Intra-Aortic Balloon Pumps (IABP) | May 31, 2018
May 31, 2018 — The results from the Survival Improvement in Extensive Myocardial Infarction with PERsistent Ischemia
FDA Clears Teleflex Arrow AC3 Optimus Intra-Aortic Balloon Pump (IABP)
Technology | Intra-Aortic Balloon Pumps (IABP) | May 02, 2017
May 2, 2017 — The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the Teleflex Inc.
Impella CP heart pump, TCT 2016, intra-aortic balloon counterpulsation, IABP, clinical study
News | Intra-Aortic Balloon Pumps (IABP) | January 03, 2017 | Dave Fornell
The Impella CP heart pump (Abiomed) demonstrated no improvement in mortality for patients with myocardial infarction...
Teleflex, Arrow IAB catheter, intra-aortic balloon pump, worldwide recall
News | Intra-Aortic Balloon Pumps (IABP) | March 11, 2016
Teleflex Inc. announced the worldwide recall of Arrow International intra-aortic balloon catheter kits and percutaneous...
Overlay Init