Teleflex Incorporated (NYSE: TFX), a leading global provider of
medical technologies, today announced the completion of patient
enrollment in a clinical study evaluating the performance of
Teleflex specialty catheters and coronary guidewires in Chronic
Total Occlusion (CTO) percutaneous coronary intervention (PCI)
procedures—currently an investigational indication for these
products. The study enrolled 150 patients across 13 investigational
sites in the US and completed enrollment three months ahead of
schedule. 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 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, MD3, Director, Interventional Cardiology and Chief of the
Piedmont Heart Institute and Cardiovascular Service Line, Atlanta,
GA, and Dimitri Karmpaliotis, MD, Director of CTO, Complex and
High-Risk PCI at Columbia University Irving Medical Center. “The
fast enrollment in the CTO-PCI study reflects the strong interest
in further advancing contemporary techniques in CTO
revascularization—the most demanding PCI environment,” said Dr.
Kandzari.
In addition to measuring procedure success and the absence of
major adverse cardiac events (MACE), the study is evaluating 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).
Enrolling 30 of the 150 patients, Khaldoon Alaswad, MD3,
Director, Cardiac Catheterization Laboratory at Henry Ford
Hospital, Detroit, MI, was the lead enroller in the study. “The
study results will enhance the CTO-PCI skill set and inform
interventionalists about the performance of the Teleflex product
line in CTO procedures,” said Dr. Alaswad.
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.
“We are very encouraged by the brisk enrollment in the CTO-PCI
IDE study and look forward to the results,” said Teleflex Medical
Director, Dr. Christopher Buller.
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.
© 2021 Teleflex Incorporated. All rights reserved. MC-007026 Rev
0.1
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.
3. Drs. Kandzari and Alaswad are paid consultants of Teleflex or
its affiliates.
Source:
Teleflex IncorporatedJake ElguiczeTreasurer and Vice President,
Investor Relations610-948-2836
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