Medtronic PLC's minimally invasive stent graft system has received the U.S. Food and Drug Administration's breakthrough device designation for the treatment of a certain heart condition.
The stent graft system, called Valiant TAAA, will receive priority review under the designation, according to Medtronic's Oct. 8 press release.
Valiant TAAA is being evaluated in five studies for thoracoabdominal aortic aneurysm, a condition characterized by an abnormal bulging of the aorta extending from the chest to the abdomen, which can cause pain and life-threatening bleeding.
Because the aorta is the largest artery in the body and delivers blood from the heart to the rest of the body, treatment of TAAA can be complex. Standard of care is complex open surgery, a high-risk procedure with a 25% death rate, Medtronic said. In addition, 40% of TAAA patients are not eligible for the procedure.
Valiant TAAA is placed inside the aneurysm in a transcatheter endovascular aortic repair procedure to seal the aortic aneurysm. The stent graft, which does not require open surgery, would support the aorta and prevent rupture, Medtronic's website said.
