Design of Valiant Navion “improves upon current-generation TEVAR”

142
Fabio Verzini

In the Aortic Podium 1st session at the 2019 Charing Cross Symposium (CX; 15–18 April, London, UK), Fabio Verzini (Turin, Italy) reported the 30-day clinical results of the complete Valiant Navion (Medtronic) cohort. He told delegates that the acute performance results for the thoracic endovascular aortic repair (TEVAR) device are encouraging, with no access or deployment failures in tortuous anatomy. Furthermore, according to Verzini, Valiant Navion has an improved design compared with current generation TEVAR devices.

He explained that the Valiant Navion system was designed to address the challenges of current-generation TEVAR devices, such as a need to “reduce movement and manipulations in the arch, enhance conformability/apposition to complex anatomy, expand stent graft configuration options, and have a lower crossing profile to expand patient applicability”. Therefore, Valiant Navion has a low-profile delivery system (to expand patient applicability), broader size options (to tailor treatment to a patient’s anatomy), and is flexible and conformable to enhance the seal.

Additionally, the device is available in two configurations: “FreeFlo”, which has a 2cm landing zone, allows perfusion into the proximal vessels, and a tip-capture mechanism; and “CoveredSeal”, which has a 2.5cm landing zone, is designed to completely cover the proximal end, and (like the FreeFlo configuration) has a tip-capture mechanism.

In the study, 100—40 of whom were women—underwent TEVAR with the device. Of these, 73.7% had high access artery tortuosity and 86.5% had high thoracic aorta tortuosity. Furthermore, the mean fluoroscopy time was 12.1±9 minutes—which Verizni said was “very short”—and 49% of patients received percutaneous access. There were no access or deployment failures.

The rate of perioperative mortality was 2%, the endoleak rate was 4.3%, and the rate of secondary procedures was 2%. Verizni commented that the 30-day rate of major adverse events was 27% but this was “in the expected range” for TEVAR and there were no major, disabling, neurological events. Of the minor strokes that did occur (two hemispheric strokes and two posterior strokes), all were resolved (with antiplatelet therapy where appropriate).

Summing up his presentation, Verzini stated that “Valiant Navion’s design improves upon
current generation TEVAR,”. He added: “The acute performance is encouraging; there were no access or deployment failures, procedure and fluoroscopy times were low, and endoleaks were rare with low rates of secondary procedures.”

The Valiant Navion is both US Food and Drug Administration (FDA) and CE mark approved for all lesions of the descending thoracic aorta: aneurysms, dissections, transections, aortic intramural haematoma, and penetrating aortic ulcers.

(Visited 53 times, 1 visits today)

LEAVE A REPLY

Please enter your comment!
Please enter your name here