Medtronic Receives CE Mark Approval for the Valiant Navion(TM) Thoracic Stent Graft System
November 13 2018 - 8:00AM
Lower-Profile
Thoracic Endovascular Aortic Repair (TEVAR) Device Broadens
Treatable Patient Population with Thoracic Aortic Disease
DUBLIN - November 13, 2018
- Medtronic plc (NYSE:MDT) today announced it
has received CE Mark approval for the Valiant Navion(TM) thoracic
stent graft system for the minimally invasive repair of all lesions
of the descending thoracic aorta, including thoracic aortic
aneurysms (TAA), blunt traumatic aortic injuries (BTAI),
penetrating atherosclerotic ulcers (PAU), intramural hematomas
(IMH), and type B aortic dissections (TBAD). This news also follows
the recent U.S. FDA approval of the Valiant Navion system.
"In clinical practice we often see patients with a
wide range of thoracic aortic anatomies. For example, TEVAR in
females doubles the risk of needing an adjunctive iliac access
procedure1, which can potentially add risk, time, and cost to the
procedure," said Professor Fabio Verzini, M.D., Ph.D., associate
professor of Vascular Surgery, University of Turin, Italy and
European principal investigator for the Valiant Navion IDE study.
"The approval of Valiant Navion gives us the ability to broaden the
treatable patient population with thoracic aortic disease,
including more female patients and those who were previously
considered ineligible for TEVAR with a percutaneous approach."
The Valiant Navion system is a lower-profile
evolution of the market-leading Valiant(TM) Captivia(TM) thoracic
stent graft system, which has treated more than 100,000 patients
globally. Valiant Navion is built on the design philosophy of the
Valiant Captivia system for improved performance and increased
patient applicability. The system also features the CoveredSeal
(proximal covered) and FreeFlo (proximal bare metal) stent
configurations - both with tip-capture accuracy, providing
physicians with two graft options to treat varying patient
anatomies and pathologies.
Approval was based on 30-day primary endpoint
analysis of 87 subjects consecutively enrolled in the
international, multicenter, prospective investigational device
exemption (IDE) study analyzing the safety and efficacy of Valiant
Navion in subjects with TAA and PAU. The results demonstrated
efficacy in both FreeFlo and CoveredSeal configurations, with no
instances of access or deployment failures at implant in the full
study cohort. Through 30 days, data showed low rates of
peri-operative mortality at 2.3 percent and secondary procedures at
2.3 percent. The rate of Type Ia endoleaks was 1.2 percent at
one-month imaging follow-up.
"In just a few short weeks, we have achieved
significant momentum with Valiant Navion - obtaining both FDA and
CE Mark approvals," said John Farquhar, vice president and general
manager of the Aortic business, which is part of the Cardiac and
Vascular Group at Medtronic. "We're proud to introduce the Valiant
Navion system in Europe and believe in its potential to expand
treatment options for physicians and patients with thoracic aortic
disease."
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 86,000 people worldwide, serving physicians,
hospitals and patients in more than 150 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 Deery SE et al. Female
sex independently predicts mortality after thoracic endovascular
aortic repair for intact descending thoracic aortic aneurysms. J
Vasc Surg. 2017 Jul;66(1):2-8. doi:
10.1016/j.jvs.2016.12.103.
Contacts:
Julia Baron Fuller
Public Relations
+1-858-692-2001
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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information contained therein.
Source: Medtronic plc via Globenewswire
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