The newest Valiant graft is designed for minimally invasive repair of TAAA, a complex condition that causes a bulging of the aorta. The standard of care is open surgery, which is associated with high morbidity and mortality, and 40% of patients are not considered candidates for treatment, according to a news release.
Medtronic said the device is intended as an off-the-shelf endovascular solution with a size matrix to enable broad patient applicability. It is currently being evaluated in the U.S. within five physician-sponsored IDE trials for the treatment of TAAA.
“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,” VP & GM of aortic business John Farquhar said in prepared remarks. “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.”
“Breakthrough designation from the FDA means that we will be able to deliver this much needed treatment to patients sooner than expected,” added chief of the division of vascular surgery at the University of South Florida Morsani School of Medicine Dr. Murray Shames. “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.”
The Valiant TAAA is the latest in Medtronic’s line of Valiant stent grafts. The Valiant Navion thoracic stent graft system intended for use in minimally invasive procedures to repair lesions in the descending aorta won FDA clearance in October 2018 and CE Mark approval in November 2018.
The Valiant Navion LSA branch thoracic stent graft system was granted breakthrough designation from the FDA in May for the delivery of treatment options for patients in need of left subclavian artery coverage during thoracic endovascular aortic repair.
Shares of MDT were down -1.8% at $105.33 per share in midday trading today.