A Medical Device Daily
Medtronic (Minneapolis) yesterday reported that it has submitted the final module of its pre-market approval (PMA) application to the FDA for approval to market and sell its Talent thoracic stent graft system.
The Talent system is designed to provide a minimally-invasive treatment alternative to open surgery for patients who develop life-threatening aneurysms in the upper portion of the aorta, the body’s largest artery.
Thoracic aneurysms affect about 30,000 people annually in the U.S., causing thousands of deaths.
Patients typically have no symptoms from aneurysms and, when they are diagnosed, often undergo complex open surgical repair. Many of these patients have other serious conditions such as coronary artery disease, high blood pressure or diabetes that make surgery difficult or even impossible. For those patients, conservative medical management or “watchful waiting” is sometimes selected as a treatment option. However, this can lead to increased mortality and morbidity.
The procedure involves threading the stent graft through a small opening in the femoral artery of the leg. The stent graft is advanced under fluoroscopic guidance to the site of the thoracic aortic aneurysm, where it is then positioned and deployed from the delivery system. Once deployed, the stent graft expands to fit snugly within the diameter of the aorta, providing a new path for the blood flow.