Medtronic (NYSE:MDT) said today that it received Shonin approval and launched its Valiant Navion thoracic stent graft system in Japan for the minimally invasive repair of thoracic descending aortic aneurysms and Type B aortic dissections.
The Fridley, Minn.-based company said it is the third major geographical launch of the Valiant Navion system after it won FDA and CE Mark approvals in 2018.
With Valiant Navion, Medtronic sets out to offer a second stent graft option alongside its Valiant Captivia thoracic stent graft system. The Valiant Navion offers CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations for the treatment of challenging thoracic aorta pathologies.
Director of the Japanese Society for Vascular Surgery Dr. Hideyuki Shimizu served on the team of physicians that oversaw the treatment of Japan’s first patients to undergo procedures with the Valiant Navion at the Keio University of Medicine, according to a news release.
“In Japan, patients experience greater aortic fragility in acute dissection compared to North America and Europe,” Shimizu said in prepared remarks. “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. 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,” added VP & GM of Medtronic’s aortic business John Farquhar. “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.”
Shares of MDT were down -0.4% at $108.14 per share in midday trading today.
