WAYNE, Pa.--(BUSINESS WIRE)--Feb. 4, 2019--
Teleflex Incorporated (NYSE: TFX), a leading global provider of medical
technologies for critical care and surgery, has announced that it
received premarket approval (PMA) from the U.S. Food and Drug
Administration for the MANTA™ Vascular Closure Device – the first
commercially available biomechanical vascular closure device designed
specifically for large bore femoral arterial access site closure.
The MANTA™ Vascular Closure Device is indicated for closure of femoral
arterial access sites while reducing time to hemostasis following the
use of 10-20F devices or sheaths (12-25F OD) in endovascular
catheterization procedures.
The SAFE MANTA IDE Clinical Trial, the largest US prospective
multi-center, single-arm trial of a purpose-designed large bore femoral
access site closure, demonstrated that the MANTA™ Device successfully
achieves fast reliable biomechanical closure with rapid hemostasis, with
all primary and secondary endpoints met.1 With its innovative
design, the MANTA™ Device has the potential to reduce bleeding
complications and offset other procedural costs.1a
“I am very encouraged by the results of the SAFE MANTA IDE Clinical
Trial. The clinically proven major complication rate (as defined by the
study protocol) of 5.3% and VARC-2 Major Vascular Complications rate of
4.2% compare very favorably to suture mediated devices and the 24 second
median time (65 second mean time) from deployment to hemostasis was
impressive,” said Dr. Zvonomir Krajcer2, lead enroller and
Co-Principal Investigator of the SAFE MANTA IDE Clinical Trial and
Co-Director of the Peripheral Vascular Disease Service at Texas Heart
Institute in Houston, Texas. “We have been patiently waiting for this
approval, are eager to use the MANTA Device commercially and look
forward to the efficiencies it can provide.”
“Our team has been working hard to obtain FDA premarket approval and
were confident they would recognize the benefits that the MANTA™ Device
can provide to the patient,” said Greg Walters, co-inventor of the
MANTA™ Device and now Vice President of Access and Closure in the
Interventional business unit of Teleflex. “We have had great success
with the device in Europe over the last two years with over 10,000 units
sold, and are thrilled to bring this innovative solution to patients in
the U.S. and further fulfill this significant and previously unmet
clinical need in the structural heart and endovascular space.”
With the MANTA™ Device, clinicians and hospitals can achieve:
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Successful large bore closure with a device that is simple to use and
does not require pre-closure, saving valuable time during the most
delicate interventional procedures.
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Low complication rates for fast reliable biomechanical closure with
rapid hemostasis, potentially reducing costs.1a,b
-
Reproducible results, inspiring confidence in achieving successful
closure.1c
“FDA premarket approval is another important milestone for the MANTA™
Vascular Closure Device,” said Stewart Strong, President and General
Manager of the Interventional business unit of Teleflex. “Our commercial
efforts in 2019 will include a measured launch of the MANTA™ Device to
ensure strong initial outcomes with key thought leading physicians as we
further invest in building the commercial infrastructure to support the
long-term growth of MANTA™ Device revenues.”
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 access, interventional
cardiology and radiology, anesthesia, emergency medicine, surgical,
urology 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®,
UroLift®, 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, Deknatel, Hudson RCI, LMA, MANTA,
Pilling, Rusch, UroLift, and Weck are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
© 2019 Teleflex Incorporated. All rights reserved. MC-005246
References:
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Data on file at Teleflex. The SAFE MANTA IDE Clinical Trial:
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MANTA™ Device demonstrated a time to hemostasis of 24 seconds
median time (65 seconds mean time) from deployment to hemostasis.
-
Rate of time to hemostasis for MANTA™ Device demonstrated from
deployment to hemostasis.
-
Percutaneous vascular closure obtained with the MANTA™ Device
without the use of unplanned endovascular or surgical intervention.
Study sponsored by Teleflex Incorporated or its affiliates.
-
Dr. Zvonomir Krajcer is a paid consultant of Teleflex Incorporated or
its affiliates.
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Source: Teleflex Incorporated
Teleflex Incorporated
Jake Elguicze
Treasurer and Vice
President, Investor Relations
610-948-2836