Teleflex Receives FDA Clearance for Expanded Indication for QuikClot Control+™ Hemostatic Device Usage in Cardiac Surgical Procedures
01 Agosto 2023 - 7:30AM
Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, today announced the U.S Food and Drug
Administration (FDA) has cleared the QuikClot Control+™ Hemostatic
Device to include mild and moderate bleeding in cardiac surgical
procedures and bone surface bleeding following a sternotomy. This
allows clinicians to use the QuikClot Control+™ Device to control
all bleeding in cardiac surgical procedures.
The expanded indications enable device utilization across a
wider patient population and breadth of surgical procedures. With
Teleflex research showing more than 600,000 open cardiothoracic
procedures are performed in the U.S. each year, cardiovascular and
cardiothoracic surgeons now have an additional solution for
intraoperative bleeding control. The QuikClot Control+™ Hemostatic
Device also received expanded intended uses to include use with
patients on anticoagulation/antiplatelet medication, use with or
without autotransfusion (blood salvage) equipment, and use with or
without cardiopulmonary bypass systems.
The FDA clearance follows the completion and analysis of the
2021 cardiac investigational device exemption (IDE) study, which
examined the percentage of patients who achieved hemostasis in the
first 10 minutes of hemostatic application and compression at the
bleeding site, as well as safety outcomes. The study, recently
published in The Journal of Thoracic and Cardiovascular Surgery
(JTCVS) Open, concluded that the QuikClot Control+™ Hemostatic
Device was superior to standard gauze in achieving clinical
hemostasis for mild and moderate cardiac surgery bleeding.1
Additionally, there was no significant difference in safety
outcomes. Study participants receiving the QuikClot Control+™
Hemostatic Device achieved hemostasis at more than 20% higher
proportion at both 5 and 10 minute intervals when compared to those
receiving standard gauze.1
“We are excited to provide an additional tool to address
bleeding control for cardiac surgeons,” said Kevin Robinson,
President and General Manager, Anesthesia and Emergency Medicine
Division, Teleflex. “We look forward to supporting positive patient
outcomes in these procedures through the expanded use potential of
our QuikClot Control+™ Devices.”
About Teleflex IncorporatedTeleflex 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™, LMA™, Pilling™,
QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united
by a common sense of purpose.
Forward-Looking StatementsAny 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, LMA, Pilling,
QuikClot, QuikClot Control+, Rüsch, UroLift, and Weck are
trademarks or registered trademarks of Teleflex Incorporated or its
affiliates, in the U.S. and/or other countries.© 2023 Teleflex
Incorporated. All rights reserved. MC-008284
References:
- Mumtaz M, Thompson RB, Moon MR, Sultan I, Reece TB, Keeling WB,
DeLaRosa J. (2023). Safety and efficacy of a kaolin-impregnated
hemostatic gauze in cardiac surgery: A randomized trial. JTCVS
Open. 2023;14:134-144.
Contacts:Teleflex Incorporated:Lawrence
KeuschVice President, Investor Relations and Strategy
Development
investors.teleflex.com610-948-2836
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