Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, today announced the first patient enrollment
in a clinical study that will evaluate the performance of Teleflex
coronary guidewires and specialty catheters in Chronic Total
Occlusion (CTO) percutaneous coronary intervention (PCI)
procedures, which is currently an investigational indication for
these products. Enrolling up to 150 patients across approximately
15 investigational sites in the US, the CTO-PCI Study is a
prospective, single-arm IDE study employing the primary
angiographic endpoint of successful (intralumenal) guidewire
placement beyond the CTO.
CTOs are longstanding complete blockages in coronary
arteries that usually result in profound regional reduction of
coronary blood flow (ischemia). Clinically significant CTOs
are found in nearly 20% of patients undergoing diagnostic coronary
angiography for suspected ischemic heart disease.1 Often a source
of limiting symptoms, CTOs may also contribute to cardiac
dysfunction and are associated with poor prognosis.2
The principal investigators of the study include David E.
Kandzari, MD, Director, Interventional Cardiology and Chief
Scientific Officer at Piedmont Heart Institute, Atlanta, GA, and
Dimitrios Karmpaliotis, MD, Director of CTO, Complex and High-Risk
PCI at Columbia University Irving Medical Center. “We’re excited to
embark on the Teleflex CTO study,” said Dr. Kandzari. “We expect
the study results to inform contemporary technique in CTO
revascularization—a lesion complexity that has long been recognized
as the most challenging in interventional cardiology.”
In addition to measuring procedure success and the absence of
major adverse cardiac events (MACE), the study will evaluate the
frequency of successful recanalization, frequency of MACE
in-hospital and at 30 days post-procedure, frequency of clinically
significant perforation, procedural success according to crossing
technique, and technical success (defined as successful guidewire
recanalization using Teleflex study devices).
Study devices include the GuideLiner® V3 catheter, TrapLiner®
catheter, Turnpike® catheter, and a series of five coronary
guidewires (SpectreTM Guidewire, R350TM Guidewire, RaiderTM
Guidewire, WarriorTM Guidewire and BanditTM Guidewire). Each study
device is currently commercially available in the US under a more
general indication. These products are investigational devices for
clinical evaluation as used in the CTO-PCI study.
“The CTO-PCI study, led by Drs. Kandzari and Karmpaliotis, will
evaluate the performance of the entire range of Teleflex complex
PCI products in the most demanding PCI environment: chronic
occlusive coronary disease,” said Teleflex Medical Director, Chris
Buller, MD. “The resourcing of this study by Teleflex reflects our
commitment to providing the most advanced tools for our customers
and their patients.”
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, Bandit, GuideLiner, R350, Raider,
Spectre, TrapLiner, Turnpike, Warrior, Arrow, Deknatel, Hudson RCI,
LMA, Pilling, Rusch, UroLift, and Weck are trademarks or registered
trademarks of Teleflex Incorporated or its affiliates, in the U.S.
and/or other countries.
© 2020 Teleflex Incorporated. All rights reserved. MC-005909 Rev
1
References:
1. Fefer, P. et al. Current Perspectives on Coronary Chronic
Total Occlusions: The Canadian Multicenter Chronic Total Occlusions
CTO Registry. Journal of the American College of
Cardiology 2012;59 (11): 991-7.
2. Tajstra, P. et al. Impact of Chronic Total Occlusion of the
Coronary Artery on Long-Term Prognosis in Patients With Ischemic
Systolic Heart Failure: Insights From the COMMIT-HF Registry. JACC:
Cardiovascular Interventions 2016; 9 (17): 1790-97.
Source:
Teleflex Incorporated Jake Elguicze Treasurer and Vice
President, Investor Relations 610-948-2836
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