Medtronic Valiant Captivia Demonstrates Safety and Efficacy at Three Years
September 20 2016 - 12:30PM
New Clinical Data
Presented in Complicated Type B Aortic Dissection at VIVA
2016
DUBLIN and LAS VEGAS - Sept. 20,
2016 - Medtronic plc (NYSE: MDT) today announced new data,
demonstrating safety and efficacy at three years in acute
complicated Type B aortic dissection patients treated with the
Valiant® Captivia®
Thoracic Stent Graft System. Ali Azizzadeh, MD, FACS, University of
Texas Health Science Center in Texas presented the new clinical
data in a late-breaking trial session at Vascular Interventional
Advances (VIVA) 2016.
An acute aortic dissection is a serious condition
in which the inner layer of the aorta tears, blood surges through
the tear, and causes the inner and middle layers of the aorta to
separate. This can result in aorta rupture or malperfusion of the
vessels originating from the dissected aorta, leading to high
morbidity and mortality. A type B dissection is a tear
located in the descending aorta.
"Evidence shows that patients with acute
complicated Type B aortic dissections can be safely and effectively
treated with thoracic endovascular aortic repair (TEVAR)," said Dr.
Azizzadeh. "The Valiant Captivia System continues to produce
positive outcomes through three years in a very challenging patient
population."
The FDA-approved Valiant Captivia System
demonstrates continued safety and efficacy at three years. The data
were gathered on 50 patients in the Medtronic Valiant Captivia
Dissection IDE Trial, conducted at 16 U.S. sites.
Data highlights through
three-year follow-up:
- Freedom from all-cause mortality was 79.4
percent
- Freedom from dissection-related mortality was
90.0 percent
- No post-index procedure ruptures or
conversions
- True-lumen diameter over the stented region
remained stable or increased in 92.3 percent, false-lumen diameter
remained stable or decreased in 69.2 percent, and the false lumen
was partially or completely thrombosed in 75.0 percent of
patients
- Three patients required secondary endovascular
procedures related to the dissection
"Medtronic is committed to working with physicians
to treat more complex aortic disease and improve the lives of
patients," said Daveen Chopra, vice president and general manager
of the Aortic business, which is part of the Aortic &
Peripheral Vascular division at Medtronic. "The Valiant line of
technology leverages decades of clinical experience in continuing
to treat thoracic disease and has been used to treat more than
75,000 patients."
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 of the highest quality 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 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:
Krystin Hayward
Public Relations
+1-508-261-6512
Ryan Weispfenning
Investor Relations
+1-763-505-4626
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information contained therein.
Source: Medtronic plc via Globenewswire
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