Medtronic Expands Coronary Portfolio to Include New DxTerity(TM) Diagnostic Catheters and Suite of Tools for the Transradial ...
February 13 2017 - 9:00AM
Full Line of
Innovative Transradial Products and Comprehensive Training Programs
Reinforce Medtronic's Commitment to Optimizing the Treatment of
Heart Disease
DUBLIN - Feb. 13, 2017 -
Medtronic plc (NYSE: MDT) today announced that its market-leading
coronary portfolio will now include the DxTerity Diagnostic
Angiography Catheter line and several transradial-specific products
including the DxTerity TRA(TM), InTRAkit(TM) access kit and
TRAcelet(TM) compression device, all of which received U.S. FDA
(Food and Drug Administration) clearance and CE (Conformité Européenne) Mark for use in diagnostic
cardiac catheterization procedures and percutaneous coronary
intervention (PCI).
The DxTerity and DxTerity TRA Diagnostic Catheters
are used to determine whether or not revascularization is necessary
in patients with coronary artery disease; the DxTerity TRA
Diagnostic Catheters are specifically designed for transradial
access and allow for engagement of both coronary arteries without
catheter exchange. The InTRAkit access kit enhances the transradial
experience by providing several component pieces-ergonomic needles
that offer excellent flashback visualization,1,
2 atraumatic mini-guidewires, as well as tapered
introducer sheaths that provide kink resistance3 and
enhanced lubricity4 for easy
insertion. The TRAcelet compression device simplifies pressure
reduction post-transradial catheterization by facilitating access
site patent hemostasis (i.e., stops bleeding while maintaining
radial artery patency).5
"The global approval of the DxTerity Diagnostic
Catheters, as well as the introduction of the new Medtronic suite
of transradial products represents a significant step forward for
patients requiring PCI procedures," said Sunil Rao, M.D.,
interventional cardiologist and associate professor of medicine at
Duke University, in Durham, N.C. "It's increasingly important
to have a full suite of products accompanied by robust training to
increase physician utilization, improve patient comfort and enable
same-day discharge."
In the United States, Medtronic also launched the
Transradial Arc CurriculumSM, a
fully-customizable education and training solution for physicians,
staff and administrators to ensure successful adoption of the
transradial approach from access to patent hemostasis. The
curriculum aims to provide robust clinical training and enhance
patient care pathways through a hospital-specific approach to help
institutions optimize the delivery of transradial care.
"Our new line of comprehensive transradial
products and programs that support PCI from start to finish were
developed to meet the evolving clinical and health economic needs
of physicians, administrators and cath lab teams around the globe,"
said Jason Weidman, vice president and general manager of the
Coronary and Renal Denervation business, which is part of the
Cardiac and Vascular Group at Medtronic. "Our intent with these
recent innovations in our premium product portfolio is to help
accelerate adoption of the transradial approach so that more
patients and hospitals may experience the advantages transradial
access can bring."
A meta-analysis of randomized studies that studied
the transradial approach generally have found that procedures via
the transradial approach (through a patient's wrist) have been
associated with cost savings,6, 7,
8 reduced mortality and improved safety with reductions
in major bleeding and vascular complications.9
The DxTerity and DxTerity TRA Diagnostic
Catheters, TRAcelet compression device and the InTRAkit Access Kit
are commercially available in the U.S., as well as throughout
Europe. The Transradial Arc Curriculum is only available in the
U.S.
In collaboration with leading clinicians,
researchers and scientists worldwide, Medtronic offers the broadest
range of innovative medical technology for the interventional and
surgical treatment of cardiovascular disease and cardiac
arrhythmias. The company strives to offer products and services
that deliver clinical and economic value to healthcare consumers
and providers around the world.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is among the world's largest medical technology, services
and solutions companies - alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 88,000 people worldwide, serving physicians,
hospitals and patients in more than 160 countries. The company is
focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements
are subject to risks and uncertainties such as those described in
Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from
anticipated results.
-end-
1 Preclinical
studies on file at Medtronic. Preclinical data may not be
indicative of clinical results.
2 Based on
physician feedback during preclinical study and compared to
participants' current clinical experience; data on file at
Medtronic.
3 Bench
test data on file at Medtronic. Bench test data may not be
indicative of clinical results.
4 Bench
test data on file at Medtronic. Bench test data may not be
indicative of clinical results.
5 Data on
file at Medtronic
6 Amin AP
et al. J Am Coll Cardiol. 2012;59;E338.
7 Jolly SS
et al. The Lancet.
2011;377(9775):1409-1420.
8 Ewen et
al. J Interv Cardiol. 2009;22(3):266-273.
9 Giuseppe
F et al. J Coll Cardiol Intv
2016;9:1419-34.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
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