Medtronic, a medical technology company based in Minneapolis, Minnesota, received expanded approval from the United States Food and Drug Administration for its Valiant grafting system. The Valiant thoracic stent grafting system is designed for the treatment of lesions found in the the descending thoracic aorta.
The Valiant stent grafting system has received FDA approval for the treatment of all DTA lesions. In addition, the Captivia delivery system used by the stent grafting device has also received expanded approval. However, both systems are not approved for the treatment of dissections.
According to a report by the FDA, the Valiant / Captivia system is the second endovascular stent grafting device that has been approved for the treatment of isolated lesions found in the thoracic aorta.
The company first received PMA approval for its Valiant system in April of last year. However, the device was only designated for use in "fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy," according to information found in an FDA regulatory notice.
The Valiant thoracic stent graft system consists of a specialized polyester tube with a metallic outer stent that can self-expand. This apparatus is then compressed into a catheter. After insertion into a catheter, the entire assembly is surgically threaded into a patient's thoracic aorta. Once there, the sheath around the Valiant stent is removed. This allows a surgeon to treat any vessel damage that is present.