The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
The Valiant TAAA is currently being evaluated in the U.S. within five physician-sponsored investigational device exemption (PS-IDE) trials for treatment of TAAA. The Valiant TAAA is intended to offer an off-the-shelf endovascular solution with a size matrix to enable broad patient applicability for one of vascular surgery's most difficult pathologies.
"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," said Murray Shames, M.D., professor and chief division of Vascular Surgery at the University of South Florida Morsani School of Medicine and an investigator for the Valiant TAAA. "Physicians and industry must continue to innovate and provide hope for those with challenging disease states."
TAAA typically involves the branch arteries that supply blood to multiple internal organs and represents about 15% of all thoracic aneurysms. The standard of care is complex open surgery, which is associated with high morbidity and mortality, and 40% of patients are not considered candidates for treatment.
"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 the Aortic business, which is part of the Cardiac and Vascular Group at Medtronic. "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."