FDA Gives Nod to Lower-Profile Thoracic Stent Graft

Patrice Wendling

Disclosures

October 23, 2018

Medtronic has announced US Food and Drug Administration approval of its Valiant Navion thoracic stent graft system designed for minimally invasive repair of all lesions of the descending thoracic aorta.

The Valiant Navion system is a lower-profile evolution of Medtronic's Valiant Captivia thoracic stent graft system and features proximal CoveredSeal and bare metal FreeFlow stent configurations.

"Until now, patients with small iliac arteries were considered ineligible for thoracic endovascular aneurysm repair (TEVAR) or required adjunctive procedures to accommodate calcification and tortuosity concerns," a company news release states. "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."

This includes patients with thoracic aortic aneurysms, blunt thoracic aortic injuries, penetrating atherosclerotic ulcers, intramural hematomas, and aortic type B dissections.

Approval of the device was supported by a 30-day analysis of 87 consecutive patients with thoracic aortic aneurysms and penetrating atherosclerotic ulcers in an international investigational device exemption (IDE) study, in which 38% of patients were women and 71.3% had severe to life-threatening systemic disease.

The FreeFlow configuration was successfully implanted in 74.7% of procedures in the full cohort and the CoveredSeal configuration in 25.3%, according to the company.

Half of the procedures (50.6%) were performed percutaneously, with mean procedural and fluoroscopy times of 88.7 minutes and 12.2 minutes, respectively.

Through 30 days, rates of perioperative mortality were 2.3%, secondary procedures 2.3%, and type 1a endoleaks 1.2%.

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