Medtronic Valiant Navion thoracic stent graft system was approved in Japan. It consists of a low-profile delivery system with FreeFlo and CoveredSeal proximal stent-graft options. It got FDA approval in October 2018, and CE mark in November 2019.
It is indicated for the endovascular repair of all lesions of the descending thoracic aorta (DTA). It has a design of 18-22Fr.
Hideyuki Shimizu, M.D., Ph.D., director of the Japanese Society for Vascular Surgery said “In Japan, patients experience greater aortic fragility in acute dissection compared to North America and Europe,” Shimizu said in the press release. “In my experience, Valiant Navion’s 18F 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.”
In addition to that John Farquhar, vice president, and general manager of the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic added, “In just one year, the Valiant Navion system has achieved significant impact in expanding minimally invasive treatment options to patients globally. 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 the 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.”