Medtronic’s Valiant Navion TEVAR Device Approved and Launched in Japan
October 31, 2019—Medtronic announced the launch of the Valiant Navion thoracic stent graft in Japan, where the Ministry of Health, Labour and Welfare granted it Shonin approval for the endovascular repair of thoracic descending aortic aneurysms and complicated type B aortic dissections (TBADs).
According to Medtronic, the Valiant Navion system features the company’s CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configuration—both with tip capture accuracy. The low-profile Valiant Navion system improves on the performance of the company’s Valiant Captivia thoracic stent graft system and broadens patient applicability. These grafts provide physicians with two options for managing challenging thoracic aorta pathologies, including fragile aortas.
Hideyuki Shimizu, MD, 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 Professor of Surgery and Cardiovascular Surgery.
Dr. Shimizu, who also serves as Director of the Japanese Society for Vascular Surgery, commented in company’s announcement, “In Japan, patients experience greater aortic fragility in acute dissection compared to North America and Europe. In my experience, Valiant Navion’s 18-F profile allows physicians to treat smaller and more tortuous 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. This device allows Japanese physicians to more precisely treat a variety of patient anatomies and pathologies with narrow vessel access.”
In October 2018, Medtronic announced FDA approval of the Valiant Navion device in the United States for thoracic endovascular aneurysm repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas, and TBADs. The company announced European CE Mark approval of the Valiant Navion in November 2018.