Medtronic Unveils New Aortic and Peripheral Data from Two Late-Breaking Clinical Trials at VIVA 2015
November 02 2015 - 12:30PM
Meeting Highlights
New Two-Year Data with Valiant Thoracic Stent Graft in Type B
Aortic Dissection and Nine-Month Comparison Data in Leading
Treatments for Peripheral Iliac Artery Disease
DUBLIN and LAS VEGAS - Nov. 2,
2015 - Medtronic plc (NYSE: MDT) today announced new clinical
data in interventional treatments for aortic and peripheral
vascular diseases in a late-breaking trial session at Vascular
Interventional Advances (VIVA) 2015.
Valiant Captiva Demonstrates
Safety and Efficacy at Two Years in Complicated Type B Aortic
Dissection Patients
Positive two-year clinical data were presented
today for the Valiant Captivia Thoracic Stent Graft System for the
treatment of complicated type B aortic dissection. Type B aortic
dissection is a serious cardiovascular condition associated with
high morbidity and mortality in which the layers of the aorta (the
body's main artery) become separated from one another. The data
were presented by Ali Azizzadeh, MD, FACS, University of Texas
Health Science Center in Texas.
The FDA-approved Valiant Captivia System
demonstrates continued safety and efficacy at two years. The data
were gathered on 35 patients in the Medtronic Valiant Captivia
Dissection IDE Trial, conducted at 16 U.S. sites. The one year
outcomes in the trial were recently published in the Annals of Thoracic Surgery.
Data highlights:
- No post-index procedure ruptures or conversions
through two years follow-up
- No new device related adverse events reported
between the one and two year follow-ups
- No loss of stent graft integrity or stent graft
collapse through two years follow-up
- At two years follow-up, true-lumen diameter over
the stented region remained stable or increased in 85.7 percent,
false-lumen diameter remained stable or decreased in 78.6 percent,
and the false lumen was partially or completely thrombosed in 70.4
percent of patients
"There is a growing body of evidence supporting
the use of thoracic endovascular aortic repair (TEVAR) as a safe
and effective treatment for patients with acute type B aortic
dissections," said Dr. Azizzadeh. "The Valiant Captivia System has
continued to produce positive patient outcomes at two years."
Advances in Treatment of
Peripheral Artery Disease (PAD); Comparing Self-Expanding Stents
(SES) and Balloon Expanding Stents (BES)
John Rundback, MD, Holy Name Medical Center in New
Jersey presented nine-month data from unique companion studies for
patients with a diverse range of symptomatic iliac atherosclerotic
disease. The presentation compared data from three Medtronic stents
for the treatment of PAD in the DURABILITY Iliac + VISIBILITY Iliac
study. The Protégé (TM) EverFlex(TM) Self-Expanding Stent System,
the Protégé(TM) GPS(TM) Self-Expanding Nitinol Stent and Delivery
Technology and the Visi-Pro(TM) Balloon Expandable Stent
System.
In this comparison, the nine-month major adverse
event rate was 1.3% for SES and 4% percent for BES, patency rates
were similar between the two groups, both at 95.8%. These data
demonstrate safety and effectiveness and comparative utilization
patterns for balloon expandable stents and self-expanding stents in
the treatment of iliac artery atherosclerosis.
Innovation on the Horizon:
Endoanchors
With more to come at VIVA 2015, Medtronic will host a symposium on
Wednesday at noon, "Developing a Standard of Care with Endoanchors:
Translatable Treatment Algorithms From the Experts." The symposium
will feature new and recently acquired technology Heli-FX and
Heli-FX® Thoracic EndoAnchor® systems, which feature an
endovascular deployed anchor designed to attach a variety of aortic
endografts to the native vessel wall.
"Medtronic is dedicated to solving healthcare
challenges and going Further, Together to provide minimally
invasive therapy options to improve patient outcomes. VIVA has
continued to be an important stage for us in unveiling new clinical
data on the latest innovations," said Tony Semedo, president of the
Aortic and Peripheral Vascular business at Medtronic. "Our
commitment to clinical rigor and innovation in the aortic and
peripheral vascular space is well displayed this week."
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 85,000 people worldwide, serving physicians,
hospitals and patients in approximately 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-
Contacts:
Kena Hudson
Public Relations
+1-510-246-0163
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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