Sept 20, 2011 - Maquet Receives FDA Clearance for New Intra-Aortic Balloon Catheter
Maquet Cardiovascular Receives FDA 510(K) Clearance and CE Mark for
Its New Sensation Plus Intra-Aortic Balloon Catheter
Mahwah, N.J. – September 20, 2011 – MAQUET Cardiovascular, a leading provider of cardiovascular technologies, announced today that it has received both 510(k) clearance from the U.S. Food & Drug Administration (FDA) and CE mark approval from the British Standards Institution (BSi) for its new SENSATION PLUS™ 50cc 8 Fr. intra-aortic balloon catheter. The new SENATION PLUS intra-aortic balloon (IAB) catheter is the first 50cc 8 Fr. IAB catheter to combine fiber optic signal acquisition with greater hemodynamic support compared to a standard 40cc IAB catheter.
“Clinicians have been asking for an IAB that combines all of the benefits of fiber optic technology; faster initiation of therapy, easier patient management and a crisp, clean arterial pressure wave form with increased hemodynamic support”, said Deb Joseph, Vice President, Marketing and Clinical Services. “We believe that the new, state-of-the art SENSATION PLUS™ intra-aortic balloon catheter meets these needs and will enable clinicians to provide patients with improved care”.
The new 50cc 8Fr. SENSATION PLUS IAB catheter provides greater patient support, comfort and ease of use than any IAB catheter MAQUET has ever offered. SENSATION PLUS 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. This new IAB catheter also comes with two Stat Lock® IAB stabilization devices which 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. The new IAB catheter will be available for sale in October.
"SENSATION PLUS underscores MAQUET's commitment to meeting the needs of clinicians treating hemodynamically compromised patients and to improving outcomes,” said Christian Keller, President of MAQUET Cardiovascular. "Up to this point, clinicians have had to choose between greater support and the benefits of fiber optic technology. Now they can have both. SENSATION PLUS represents a new standard of care with respect to intra-aortic counterpulsation therapy".
Intra-aortic balloon counterpulsation is an adjunctive therapy that is 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.
For more information about MAQUET Cardiovascular, please visit http://ca.maquet.com
INFORMATION ABOUT MAQUET
As a trusted partner for hospitals and clinicians since 1838, Maquet is a global leader in medical systems that advance surgical interventions, cardiovascular procedures and critical care. Maquet develops and designs innovative products and therapeutic applications for the operating room, hybrid OR/cath lab, intensive care unit and patient transport within acute care hospitals, improving outcomes and quality of life for patients.
Cardiovascular specialties include intra-aortic balloon counterpulsation (IABC) therapy for cardiac assist; coronary artery bypass surgery; aortic and peripheral vascular surgery; and extracorporeal circulation.
The Critical Care portfolio includes market-leading intensive care ventilators and anesthesia machines.
Maquet also equips Surgical Workplaces with critical infrastructure such as flexible room design for OR and ICU; OR tables; lights and ceiling supply units; and OR integration for image data management.