Teleflex Receives FDA 510(k) Clearance for the Arrow® AC3 OptimusTM Intra-Aortic Balloon Pump (IABP)
Advanced IABP performance with the ability to provide optimized therapy to the most challenging patient conditions, even patients with the most severe arrhythmias and heart rates as high as 200 bpm.1
This device helps a weakened heart pump blood and can deliver IABP therapy to a broad range of patients, even those not previously considered candidates for IABP therapy. Clinicians may use the pump on patients with the most severe arrhythmias or with heart rates as high as 200 beats per minute.1, 2
In IABP therapy, a physician inserts an intra-aortic balloon catheter into an artery, and using x-ray or imaging, advances the catheter into the aorta. An IABP console, connected to the catheter, controls the inflation and deflation of the balloon.
“When a patient has an elevated heart rate or severe arrhythmia, his or
her survival can suddenly depend on the ability of the IABP to keep pace
and provide accurate therapy,” said
The AC3 Optimus IABP has a third-generation AutoPilot® Mode, which uses proprietary algorithms to address key clinical challenges and to simplify the delivery of IABP therapy.3 In AutoPilot Mode, the AC3 Optimus IABP automatically adjusts timing and triggering parameters, freeing clinicians to focus on the patient rather than the pump. In addition, the AC3 Optimus IABP includes several exclusive algorithms, such as WAVE® Inflation Timing, Deflation Timing Management, and Best Signal Analysis, which optimize key functions of the IABP to deliver therapy to the most challenging patients.
“The AC3 Optimus IABP global launch marks a major milestone for
The AC3 Optimus IABP will be launched at two key scientific meetings in
“As innovators in intra-aortic balloon pumping technology, we continue
to advance the performance and reliability of automated therapy to the
benefit of patients, clinicians, and health systems everywhere,” said
Any statements contained in this press release that do not describe
historical facts may constitute forward-looking statements. Any
forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. These risks and
uncertainties are identified and described in more detail in our filings
*Paid consultant of
Schreuder J, Castiglioni A, Donelli A, et al. Automatic intraaortic
balloon pump timing using an intra beat dicrotic notch prediction
algorithm. Ann Thorac Surg. 2005;79(3):1017-1022. Study
Donelli A, Jansen JRC, Hoeksel B, et al. Performance of a real-time
dicrotic notch detection and prediction algorithm in arrhythmic human
aortic pressure signals. J
Clin Monit. 2002;17(3-4):181-185. Study sponsored by Teleflex.
Torracca, L. Overcoming electro-surgical inference in IABP therapy
with the combined use of AutoPilot and FiberOptix IAB sensor signal.
2007. (case report, data on file). Study sponsored by
Treasurer and Vice President, Investor Relations