The FDA has issued an updated approval to Medtronic for the use of its Valiant Thoracic Stent Graft with Captivia delivery system. The approval information can be found here and extends the device’s indications for use to include all descending thoracic aorta lesions except where dissections exist.
The Valiant Thoracic Stent Graft with the Captivia Delivery System is an artificial endovascular stent graft and is used to treat vessel damage caused by disease or trauma (isolated lesions), excluding dissections, of the descending thoracic aorta during endovascular repair.
The original PMA approval for Valiant occurred in April 2011, but the device was indicated only for treatment of “fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy,”
The Valiant Thoracic Stent Graft with the Captivia Delivery System is the second endovascular stent grafting system approved to treat isolated lesions of the thoracic aorta, the other being Cook’s Zenith TX2 device. Approval of the expanded indications was evaluated with clinical studies for aneurysms and transections.