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FDA Approves Medtronic‘s Thoracic Stent Graft System

Recently, Medtronic—a medical device company—reported that a thoracic stent graft system has received approval from the FDA. This graft system is used for the therapy of individuals having an injury of the downward thoracic aorta.

According to a press release from the firm, the thoracic stent graft system known as Valiant Navion by Medtronic is utilized to fix lesions in a minimally invasive method. Along with this method, other injuries such as dull thoracic aortic injury, intramural hematomas, thoracic aortic aneurysms, aortic type B dissections, and penetrating atherosclerotic ulcers will also be treated. This new graft system is a low-profile version of other thoracic stent graft systems by Medtronic known as Valiant Captivia, CoveredSeal, and FreeFlo. This new graft system will let doctors adjust the system to various patients’ anatomies and pathologies, according to the release. Dr. Ali Azizzadeh—Director of the Division of Vascular Surgery—reported that an important decrease of the delivery system profile permits doctors to facilitate better the endovascular therapy of individuals having tortuous, smaller, and calcified access vessel arteries. Patients with smaller iliac arteries were earlier not considered eligible for thoracic endovascular aneurysm procedures. This new system will allow more patients to go through a percutaneous procedure.

Recently, the FDA was also in news for taking measures to strengthen its bona fides related to medical device security. Initially, it approved a memo of agreement along with the Department of Homeland Security. This agreement was signed to put into practice a new outline for increased cooperation and coordination between the two agencies related to medical device security grounds. The pact is done between the DHS’ CS&C (Office of Cybersecurity and Communications) and the FDA’s CDRH (Center for Devices and Radiological Health). This agreement is meant to motivate superior information sharing and coordination about confirmed or potential medical device security threats and exposure.