MedTech Medtronic nets FDA breakthrough label for aortic aneurysm-sealing stent system

Medtronic received a breakthrough designation from the FDA for its combination stent-graft system designed to […]

Medtronic received a breakthrough designation from the FDA for its combination stent-graft system designed to seal off large aortic aneurysms that span from the chest down into the abdomen.
The minimally invasive Valiant TAAA system aims to serve as a new, off-the-shelf intervention where the current standard of care is bypass surgery, according to the medtech giant.
“With an open surgery mortality rate of 25%, it is critical that we deliver for this unmet patient need,” said study investigator Murray Shames, a professor and chief of the division of vascular surgery at the University of South Florida Morsani School of Medicine. Additionally, 40% of patients are not considered candidates for surgery.
Thoracoabdominal aneurysms typically span complex anatomies, including arteries that branch off from the aorta to carry blood to internal organs. These events account for about 15% of all thoracic aneurysms, Medtronic 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,” said John Farquhar, vice president and general manager of Medtronic’s aortic business.

Designed in collaboration with Patrick Kelly, a vascular surgeon and medical device inventor who leads Sanford Health Commercialization, the Valiant TAAA system is currently being tested in five physician-led clinical trials. With the FDA designation, the agency will provide priority review and communication regarding development, trial protocols and commercialization decisions.

RELATED: FDA approves Medtronic’s slimmer Valiant Navion thoracic stent graft
A similar stent-graft system from Medtronic—the Valiant Navion LSA, designed for patients who need coverage of the aortic arch’s left subclavian artery during thoracic endovascular aortic repair procedures—also received a breakthrough designation from the FDA this past May. It’s designed off the previously approved Valiant Navion system.
“About 40% of thoracic aortic aneurysms in branch vessels involve coverage of the LSA,” said Farquhar. “With no currently available off-the-shelf solutions, surgical bypass remains the standard of care for these patients. By leveraging our low-profile, Valiant Navion platform, we hope Valiant Navion LSA will expand endovascular treatment options to those in need.”
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