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MAQUET Cardiovascular Receives FDA 510(k) Clearance and CE Mark for Its New SENSATION PLUSâ„¢ Intra-Aortic Balloon Catheter

September 20, 2011 By Bio-Medicine.Org

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

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SOURCE

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