Medtronic won European CE Mark approval to introduce its Valiant Navion thoracic stent graft for treating lesions within the descending thoracic aorta such as thoracic aortic aneurysms (TAA), blunt traumatic aortic injuries (BTAI), and penetrating atherosclerotic ulcers (PAU). The system received FDA approval in October of this year.
The Valiant Navion is particularly beneficial for patients with narrow iliac arteries, in whom previously developed minimally invasive access could has been difficult and additional procedures may have been required just to get started.
The new product is based on the Valiant Captivia thoracic stent graft system, but thanks to its narrower profile allows for improved navigation through tortuous anatomy. It comes with two different stent configurations: CoveredSeal (proximal covered) and FreeFlo (proximal bare metal). These two options give physicians an ability to treat a wide range of patients.
“In clinical practice we often see patients with a wide range of thoracic aortic anatomies. For example, TEVAR in females doubles the risk of needing an adjunctive iliac access procedure, which can potentially add risk, time, and cost to the procedure,” in a published statement said Professor Fabio Verzini, M.D., Ph.D., associate professor of Vascular Surgery, University of Turin. “The approval of Valiant Navion gives us the ability to broaden the treatable patient population with thoracic aortic disease, including more female patients and those who were previously considered ineligible for TEVAR with a percutaneous approach.”
Product page: Valiant Navion…
Flashback: FDA Approves Valiant Navion Thoracic Stent Graft for Patients with Narrow Iliac Arteries…
Via: Medtronic…