MAQUET Cardiovascular Receives FDA 510(k) Clearance and CE Mark for Its New SENSATION PLUSâ„¢ Intra-Aortic Balloon Catheter
MAHWAH, N.J., Sept. 20, 2011 /PRNewswire/ -- 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 SENSATION 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 Chr