Ireland-based medical device manufacturer Medtronic has received U.S. Food and Drug Administration (FDA) approval for the company’s new Valiant Navion thoracic stent graft system.
The system is designed for use in the minimally invasive repair of all lesions of the descending thoracic aorta, including thoracic aortic aneurysms (TAA), blunt thoracic aortic injuries (BTAI), penetrating atherosclerotic ulcers (PAU), intramural hematomas (IMH), and aortic type B dissections (TBAD).
Valiant Navion allows for the potential for more patients to receive a percutaneous procedure and overcome these anatomical concerns, enabling a less invasive approach to treatment compared to surgical cut-down (open) procedures.
"Our focus at Medtronic continues to be on advancing the treatment of complex aortic disease to improve outcomes and extend life," said John Farquhar, vice president and general manager of the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic.
"This FDA approval now makes it possible for more patients with thoracic aortic disease to receive endovascular repair. This therapy is truly a testament to our more than 20 years of clinical and engineering insights, and we look forward to making it available to those in need."
The Valiant Navion system is a lower-profile evolution of the market-leading Valiant Captivia thoracic stent graft system, which has treated more than 100,000 patients globally. Valiant Navion is built on the design philosophy of the Valiant Captivia system for improved performance and increased patient applicability.
The system also features both CoveredSeal (proximal covered) and FreeFlo (proximal bare metal) stent configurations, providing physicians with two graft options to treat varying patient anatomies and pathologies.