Medtronic 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 US Food and Drug Administration (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, 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 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.