This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Valiant Navion Thoracic Stent Graft System (Prosthetic endovascular graft)
PMA Applicant: Medtronic Vascular
Address: 3576 Unocal Place, Santa Rosa, CA 95403
Approval Date: October 19, 2018
Approval Letter: Approval Order
What is it? The Valiant Navion Thoracic Stent Graft System is an implantable stent graft (a fabric tube supported by a metal framework) intended to repair lesions in the descending thoracic aorta (large artery in the chest) through a small cut in the groin (area between the abdomen and thigh on either side of the body) without the need for a big cut in the chest. Some of these lesions include aneurysms, transections, and dissections. An aortic aneurysm is a diseased, weakened and bulging section of the aortic wall. A transection is a rupture or tear of the aortic wall, typically resulting from a traumatic force to the chest. A dissection is a condition where the inside lining of the aorta tears away from the outer wall.
The Valiant Navion Thoracic Stent Graft System is Medtronic's next generation thoracic stent graft system, based on the previously approved Valiant Captivia Thoracic Stent Graft System. The changes to the stent graft system were intended to increase the number of stent graft options, decrease the diameter of the delivery system, and allow for more controlled delivery.
How does it work? The delivery catheter containing the endovascular stent graft is inserted into a blood vessel (femoral artery) in the groin through a small cut. The delivery system is carefully guided within the artery to bridge the diseased or injured section of the aorta. After being placed in the artery, the stent graft self-expands and relieves the pressure on this section of your aorta by providing a new pathway for blood flow. This can prevent possible complications of the diseased or injured aorta such as further growth, rupture, and death.
When is it used? The Valiant Navion Thoracic Stent Graft System is used in surgeries involving a small cut in the groin instead of a big cut in the chest (minimally invasive) in patients who have lesions of the descending thoracic aorta.
What will it accomplish? The Valiant Navion Thoracic Stent Graft System may benefit patients with lesions in the aorta in the chest by preventing further growth and rupture of the lesion. If the device doesn't completely seal off the lesion from pressurized blood flow, there is a chance that additional treatment will be needed to prevent these problems.
When should it not be used? The Valiant Navion Thoracic Stent Graft System should not be used with:
- Patients who have an infection that might threaten to infect the endovascular stent graft.
- Patients who are sensitive to or allergic to the device materials (e.g., Nitinol and polyester).
Additional information (including warnings, precautions, and adverse events):