Medtronic has secured Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Valiant TAAA Stent Graft System intended for minimally invasive repair of thoracoabdominal aortic aneurysm (TAAA).

The medical device company said that its Valiant TAAA is currently being studied in five physician-sponsored investigational device exemption (PS-IDE) trials in the US, for treatment of TAAA.

Medtronic aortic business vice president and general manager John Farquhar said: “In addition to a high mortality rate for open surgical repair, physicians do not have good options when it comes to treatment for failed endografts.

“The FDA’s breakthrough designation for Valiant TAAA and our collaboration with leading physicians is an example of our willingness to take a courageous approach and challenge the limitations of current treatment options. This is about going further, together to improve patient outcomes.”

Valiant TAAA Stent Graft System offers advanced endovascular solution

A TAAA is a complex condition characterised by causing a widening of the aorta, extending from the chest down to the abdomen. The disorder affects the branch arteries that supply blood to multiple internal organs and represents about 15% of all thoracic aneurysms.

Traditionally TAAA is treated using complex open surgery as the standard of care, which is often associated with high morbidity and mortality.

Medtronic said that its Valiant TAAA Stent Graft System was developed in partnership with Patrick Kelly, a vascular surgeon and inventor focused on complex vascular diseases.

The Valiant TAAA has been designed to offer an advanced endovascular solution to enable enhanced patient applicability for one of the most difficult pathologies in vascular surgery.

University of South Florida professor and Valiant TAAA investigator Murray Shames said: “Breakthrough designation from the FDA means that we will be able to deliver this much needed treatment to patients sooner than expected.

“With an open surgery mortality rate of 25%, it is critical that we deliver for this unmet patient need. Physicians and industry must continue to innovate and provide hope for those with challenging disease states.”