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
WAYNE, Pa.--(BUSINESS WIRE)--May 2, 2017--
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical
technologies for critical care and surgery, has announced 510(k)
clearance from the U.S. Food and Drug Administration (FDA) for its AC3
OptimusTM Intra-Aortic Balloon Pump (IABP).
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 Kyle Spear*, CCP, Chief Perfusionist
at a major U.S. medical center. “The AC3 Optimus IABP does this with
precision across a wide range of patient conditions.”
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
Teleflex. This highly anticipated launch will enable the Company to
become a more significant player with a product that can enhance patient
outcomes and make it easier for clinicians to deliver IABP therapy,”
said Liam Kelly, President and Chief Operating Officer at Teleflex.
The AC3 Optimus IABP will be launched at two key scientific meetings in
May. In North America, the AC3 Optimus IABP will be on display at the
American Association for Thoracic Surgery and American Society of
ExtraCorporeal Technology (AATS/AmSECT) Annual Meeting being held April
29th-May 3rd, 2017 in Boston, MA. Additionally,
the AC3 Optimus IABP will be on display at the EuroPCR 2017 Conference
being held May 16th-19th in Paris, France. The
device has received its CE Mark and has launched in India and parts of
Europe.
“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
Stewart Strong, President and General Manager of the Interventional
Division at Teleflex. “We’ve put everything in to provide a total
solution.”
About Teleflex Incorporated
Teleflex is a global provider of medical technologies designed to
improve the health and quality of people’s lives. We apply purpose
driven innovation – a relentless pursuit of identifying unmet clinical
needs – to benefit patients and healthcare providers. Our portfolio is
diverse, with solutions in the fields of vascular and interventional
access, surgical, anesthesia, cardiac care, urology, emergency medicine
and respiratory care. Teleflex employees worldwide are united in the
understanding that what we do every day makes a difference. For more
information, please visit teleflex.com.
Teleflex is the home of Arrow®, Deknatel®, Hudson
RCI®, LMA®, Pilling®, Rusch®
and Weck® – trusted brands united by a common sense of
purpose.
Forward-Looking Statements
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
with the Securities and Exchange Commission, including our Annual Report
on Form 10-K.
Teleflex, the Teleflex logo, Arrow, AC3 Optimus, AutoPilot, Deknatel,
Hudson RCI, LMA, Pilling, Rusch, WAVE, and Weck are trademarks or
registered trademarks of Teleflex Incorporated or its affiliates, in the
U.S. and/or other countries.
© 2017 Teleflex Incorporated.
All rights reserved. MC-002727
*Paid consultant of Teleflex
References:
-
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
sponsored by Teleflex.
-
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 Teleflex.
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Source: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836