Medtronic has launched its Valiant Navion thoracic stent graft system, following the pre-market approval (Shonin) from the Japanese Ministry of Health, Labour and Welfare (MHLW).

The medical devices firm said that its Valiant Navion is used in the minimally invasive repair of thoracic descending aortic aneurysms (TAA) and complicated type B aortic dissections (TBAD).

Medtronic cardiac and vascular group aortic business vice president and general manager John Farquhar said: “In just one year, the Valiant Navion system has achieved significant impact in expanding minimally invasive treatment options to patients globally.

“Thoracic endovascular aortic repair 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.”

Valiant Navion has previously received FDA and CE Mark approvals

Medtronic has designed the low-profile thoracic stent graft system based on the existing Valiant Captivia thoracic stent graft system to further improve the performance, while also extending patient applicability.

Valiant Navion is equipped with the proximal cover CoveredSeal and proximal bare metal FreeFlo stent configurations, both with tip capture accuracy.

The Japanese regulatory approval of Valiant Navion marks the third major geographical launch, following FDA and CE Mark approvals obtained in late 2018.

The company said that its new thoracic graft system offers physicians with two graft options to manage challenging thoracic aorta pathologies such as fragile aortas.

The Japanese Society for Vascular Surgery director and Keio University of Medicine professor Hideyuki Shimizu said: “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.”

Medtronic claims that it offers a wide range of advanced medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias, in collaboration with clinicians, researchers, and scientists across the world.