Teleflex Announces Publication of “Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneou...
August 01 2019 - 6:15AM
Teleflex Incorporated (NYSE: TFX) today announced the publication
of the “Pivotal Clinical Study to Evaluate the Safety and
Effectiveness of the MANTA Percutaneous Vascular Closure Device.”
The SAFE MANTA IDE Clinical Trial, the largest U.S. prospective
multi-center study of a purpose-designed large bore femoral
arterial access site closure device to date, demonstrated the
safety and effectiveness of the MANTA™ Device.1,2 Results were
published in Circulation: Cardiovascular Interventions.
The study demonstrated that, in a selected population, the
MANTA™ Device can safely and effectively close large bore
arteriotomies created by current generation transcatheter aortic
valve (TAVR) replacement, percutaneous endovascular abdominal
aortic aneurysm (EVAR) repair, and thoracic endovascular aortic
aneurysm (TEVAR) repair devices.1 The study authors noted that open
surgical closure as well as adapted small-bore suture-based
pre-closure devices have significant limitations.1 The MANTA™
Device is innovatively designed to potentially reduce bleeding
complications and offset other procedural costs.1a
“We created the MANTA™ Device to address a previously unmet
clinical need for effective, reproducible, and safe closure of
large bore femoral arterial access sites,” 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
are excited to now have published data indicating that the MANTA™
Device can rapidly and effectively close large bore femoral
arterial access sites with good safety. We believe this has
important implications for the treatment of patients with current
generation TAVR replacement, EVAR repair, or TEVAR repair.”
The study demonstrated that the median time from deployment to
hemostasis was 24 seconds (65 second mean time).1a Technical
success was achieved in 97.7% of patients, and a single device was
deployed in 99.6% of cases.1b The IDE-defined major
complications1c, the primary safety end point for the study,
occurred in 5.3% of patients and Valve Academic Research
Consortium-2 (VARC-2) major vascular complications occurred in 4.2%
of cases.1 This VARC-2 rate is lower than published rates for
suture-mediated closure.2,3
“This published data should give physicians the confidence they
need to adopt the MANTA™ Device as their large bore femoral
arterial access site closure device of choice,” said Dr. David A.
Wood4, Co-Principal Investigator of the SAFE MANTA IDE Clinical
Trial and Director of the Vancouver General Hospital Cardiac
Catheterization Laboratory in Vancouver, British Columbia. “As we
discussed in the manuscript, the VARC-2 major vascular
complications in this study included the use of balloon inflation
or deployment of a covered stent at the access site regardless of
the absence of any eventual adverse outcome. Many prior reports of
other closure techniques have disregarded these additional, often
prophylactic, interventions when reporting VARC-2 major vascular
complications.”
“The publication of this data reflects our ongoing commitment to
invest in and provide innovations that simplify interventions,”
said Stewart Strong, President and General Manager of the
Interventional business unit of Teleflex. “To further demonstrate
this commitment to our customers, we are continuing to invest in
the MANTA™ Device through additional studies in progress in Europe
that will evaluate use of the device when encountering various
clinical challenges, including patients with heavily calcified
arteries not suited to suture-based devices.”
About the MANTA™ DeviceThe 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.
With the MANTA™ Device, clinicians and hospitals can
achieve:
- Successful large bore closure with a device that is simple to
use and does not require preclosure, saving valuable time during
the most delicate interventional procedures.
- Low complication rates for fast, reliable biomechanical closure
with rapid hemostasis, potentially reducing costs.1a,d
- Reproducible results, inspiring confidence in achieving
successful closure.1b
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®, Hudson RCI®, LMA®,
Pilling®, Rusch®, 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, 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-005744 Rev 0
References:
- Wood D, et al. Pivotal Clinical Study to Evaluate the Safety
and Effectiveness of the MANTA Percutaneous Vascular Closure
Device: The SAFE MANTA Study. Circulation: Cardiovascular
Interventions. 2019 July. Vol 12, Issue 7.
- MANTA™ Device demonstrated a time to hemostasis of 24 seconds
median time (65 seconds mean time) from deployment to
hemostasis.
- Percutaneous vascular closure obtained with the MANTA™ Device
without the use of unplanned endovascular or surgical
intervention.
- Major complications defined as composite of i) vascular injury
requiring surgical repair/stent-graft; ii) bleeding requiring
transfusion; iii) lower extremity ischemia requiring surgical
repair/additional percutaneous intervention; iv) nerve injury
(permanent or requiring surgical repair); and v) infection
requiring IV antibiotics and/or extended hospitalization
- Rate of time to hemostasis for MANTA™ Device demonstrated from
deployment to hemostasis.Study sponsored by Teleflex Incorporated
or its affiliates.
- Généreux P, et al. Vascular complications after transcatheter
aortic valve replacement. J Am Coll Cardiol. 2012 Sept
18;60(12):1043-1052.
- Lauten A, et al. Percutaneous left-ventricular support with the
Impella 2.5®-assist device in acute cardiogenic shock: results of
the Impella-EUROSHOCK-registry. Circ Heart Fail. 2013
Jan;6(1):23-30.
- This statement reflects the personal experience and opinion of
the physician.
Source:Teleflex IncorporatedJake
ElguiczeTreasurer and Vice President, Investor
Relations610-948-2836
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