Medtronic Announces FDA Clearance and U.S. Launch of the Euphora(TM) Semicompliant Coronary Balloon
May 05 2015 - 9:30AM
Company to
Launch "Cath Lab Connect" Informational Portal and Community
Website for Cath Lab Professionals
DUBLIN - May
5, 2015 - Medtronic plc (NYSE: MDT) today announced the U.S.
Food and Drug Administration (FDA) 510(k) clearance and U.S. launch
of the Euphora(TM)
Semicompliant Balloon Dilatation Catheter, a pre-dilatation therapy
used during a stent implantation to reopen a narrowed coronary
artery caused by plaque buildup. The first patient case with
the Euphora Semicompliant Balloon Catheter was recently performed
by James T. DeVries, MD, FACC, FSCAI, director of Endovascular
Intervention and associate director of the Cardiac Catheterization
Lab at Dartmouth-Hitchcock Medical Center in Lebanon, NH.
"We at Dartmouth-Hitchcock Medical Center are
pleased to have been chosen as the U.S. launch site for the
Medtronic Euphora balloon," said DeVries. "This continued access to
new technology is essential to help our patients in the ongoing
battle against coronary artery disease."
Pre-dilatation with a semicompliant balloon helps
physicians determine lesion characteristics, stent selection and
facilitates stent access to the lesions - a crucial step for
patients with challenging lesions.
The Euphora Semicompliant Balloon Catheter
features several new design advancements including:
-
Delivery system with PowerTrac(TM)
technology to provide superior deliverability (compared to major
competitors)[i] through
challenging lesions. This enhanced pushability comes from a
re-designed shaft technology first introduced with the Medtronic NC
Euphora(TM)
Noncompliant Balloon Dilatation Catheter in September 2014.
-
Ultra-slim balloon material, a tapered
proprietary inner shaft design and an optimized mini-wrap to reduce
the wall thickness of the balloon and contribute to the extremely
low crossing profile.i
-
Improved insertion and retraction force to
enhance navigation to lesion sites when using the Kissing Balloon
Technique.[ii]
-
Packaging enhancements for quicker and easier
identification by cath lab staff due to new product labeling and EZ
Pull Corners, as well as reduced box size for optimal shelf
storage.
"With the addition of the Euphora semicompliant
balloon we are able to provide physicians with one of the most
robust and best-in-class interventional product portfolios
available on the market," said Jason Weidman, vice president and
general manager of the Coronary & Renal Denervation business in
Medtronic's Coronary & Structural Heart division. "This launch
delivers on our strategy of introducing a breadth of premium
products, and exemplifies our continued commitment to deliver
innovative and differentiated technologies that address the needs
of cath lab professionals around the world."
The Euphora semicompliant balloon received CE
(Conformité Européene) mark in December 2014, and expands
Medtronic's interventional portfolio of medical devices across
Coronary, Renal Denervation and TAVR, and is one of 12 new product
introductions planned over the next two years.
Medtronic to Launch "Cath Lab
Connect"
In an effort to increase education and peer-to-peer engagement
among cath lab professionals, Medtronic today announced it
will launch "Cath Lab Connect," an informational portal and
community website dedicated to cath lab nurses and technicians. The
website, which will go live this month, will feature educational
resources for cath lab professionals, information about upcoming
events and conferences, industry news, as well as a forum for
members to connect and discuss relevant topics or share best
practices. To learn more, visit: www.cathlabconnect.com.
In collaboration with leading clinicians,
researchers and scientists, 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
worldwide.
ABOUT MEDTRONIC
Medtronic plc (www.medtronic.com), headquartered in Dublin,
Ireland, is the global leader in medical technology -- alleviating
pain, restoring health and extending life for millions of people
around the world.
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 -
[i] Competitive
Bench testing vs. Trek, Emerge(TM) and
Sprinter(TM)
Legend(TM) balloons.
2.50-mm x 15-mm balloons tested. Bench test data may not be
indicative of clinical performance. .
[ii]
Competitive Bench testing vs. Sprinter(TM)
Legend(TM) and Emerge.
Based on 6 F KBT testing. 2.50-mm x 15-mm balloons tested. Bench
test data may not be indicative of clinical performance. 3.75-mm
and 4.00-mm Euphora rapid exchange balloon models are not suitable
for simultaneous use within a 2-mm (6 F/MGCID 1.8-mm [0.070"])
guide catheter.
Contacts:
Joey Lomicky
Public Relations
+1-763-526-2494
Jeff Warren
Investor Relations
+1-763-505-2696
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX 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
HUG#1917801
Medtronic (NYSE:MDT)
Historical Stock Chart
From Aug 2024 to Sep 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Sep 2023 to Sep 2024