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 word endovascular refers to the area inside of a blood vessel such as the aorta . Endovascular stent grafting, or endovascular aortic repair (EVAR), is a newer form of treatment for thoracic aortic aneurysms that is less invasive than open surgery. Endovascular stent grafting uses a device called an endovascular stent graft.

The endovascular stent graft is a synthetic fabric tube (graft) supported by a metal scaffold (stent). During endovascular stent grafting the endovascular stent graft is placed inside your thoracic aorta using a long, thin, soft, plastic tube called a delivery catheter.

Thoracic aortic aneurysms can weaken the aorta, your body's largest blood vessel. This can be fatal if the aneurysm bursts, causing massive internal bleeding. The endovascular stent is placed inside of your thoracic aorta to help reinforce the blood vessel and prevent an aneurysm from rupturing.

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

 

Valiant Navion

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.

FreeFlow configuration

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%, subsequent procedures 2.3%, and type 1a endoleaks 1.2%.