Medtronic gets FDA breakthrough device designation for developing stent graft system to treat thoracoabdominal aortic aneurysms

Medtronic gets FDA breakthrough device designation for developing stent graft system to treat thoracoabdominal aortic aneurysms

Press releases may be edited for formatting or style | October 09, 2019 Cardiology

Continuing Expansion into Breakthrough Technologies with Valiant Navion™ LSA
The Valiant Navion™ LSA branch thoracic stent graft system received breakthrough designation from the FDA in May 2019 to allow for more timely delivery of treatment options for patients in need of left subclavian artery (LSA) coverage during thoracic endovascular aortic repair (TEVAR).

Valiant Navion LSA is based on Valiant Mona LSA investigational device and the FDA-approved Medtronic Valiant Navion stent graft system. Like Valiant Navion, the off-the-shelf, single branch device leverages a low-profile design, which may further enable patient applicability and access. The branch cuff is intended to replicate the natural anatomy of the LSA to maximize seal and patency.

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“About 40% of thoracic aortic aneurysms in branch vessels involve coverage of the LSA. With no currently available off-the-shelf solutions, surgical bypass remains the standard of care for these patients,” added Farquhar. “By leveraging our low-profile, Valiant Navion platform, we hope Valiant Navion LSA will expand endovascular treatment options to those in need. It is a matter of putting patients first and delivering innovation where it matters most.”

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, 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.

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