Medtronic Announces Shonin Approval and Launch of the Valiant Navion™ Thoracic Stent Graft System in Japan
October 31 2019 - 10:00AM
Medtronic plc (NYSE:MDT) today announced Shonin approval from
the Ministry of Health, Labour and Welfare (MHLW) and the launch of
the Valiant Navion™ thoracic stent graft system in Japan for the
minimally invasive repair of thoracic descending aortic aneurysms
(TAA) and complicated type B aortic dissections (TBAD). The news
marks the third major geographical launch of the Valiant Navion,
following FDA and CE Mark approvals in late
2018.
The low-profile Valiant Navion system is built to
further improve upon the performance of the market-leading Valiant™
Captivia™ thoracic stent graft system, which has treated more than
100,000 patients globally, while also broadening patient
applicability. With the Valiant Navion system, physicians now have
two graft options for the management of challenging thoracic aorta
pathologies, including fragile aortas. The system features the
CoveredSeal (proximal covered) and FreeFlo (proximal bare metal)
stent configurations - both with tip capture accuracy.
Hideyuki Shimizu, M.D., Ph.D, director of the
Japanese Society for Vascular Surgery, served on the team of
physicians treating the first patients in Japan to undergo a
procedure with the Valiant Navion system at the Keio University of
Medicine, where he is also a professor of surgery and
cardiovascular surgery.
“In Japan, patients experience greater aortic
fragility in acute dissection compared to North America and
Europe. In my experience, Valiant Navion’s 18F profile allows
physicians to treat smaller and more torturous anatomy while
managing patient populations with increased inflammatory states,
risks of hypertension, and aortic wall stress – all attributes and
conditions that are particularly relevant to the Japanese patient
population,” said Dr. Shimizu. “This device allows Japanese
physicians to more precisely treat a variety of patient anatomies
and pathologies with narrow vessel access.”
“In just one year, the Valiant Navion system has
achieved significant impact in expanding minimally invasive
treatment options to patients globally,” said John Farquhar, vice
president and general manager of the Aortic business, which is part
of the Cardiac and Vascular Group at Medtronic. “TEVAR is not one
size fits all. By designing a device with a global patient
population in mind, we have ultimately broadened patient
applicability and allowed for more patients to receive endovascular
repair. The success of Valiant Navion is indicative of our drive
and commitment to go further, together and deliver the best
outcomes to the most 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 MedtronicMedtronic 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 90,000 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-
Julia FullerPublic Relations+1-707-210-2069
Ryan WeispfenningInvestor Relations+1-763-505-4626
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