October 7, 2019
Medtronic Gains FDA Breakthrough Device Designations for Valiant TAAA and Valiant Navion LSA Systems
October 8, 2019—Medtronic announced the receipt of FDA Breakthrough Device designations for the company’s Valiant thoracoabdominal aortic aneurysm (TAAA) stent graft system and the Valiant Navion left subclavian artery (LSA) branch thoracic stent graft system.
According to company, the Valiant TAAA device is intended to offer an off-the-shelf endovascular solution with a size matrix to enable broad patient applicability in this difficult pathology. It is currently being evaluated in the United States in five physician-sponsored investigational device exemption trials on the treatment of TAAA.
Murray Shames, MD, an investigator of the Valiant TAAA, commented in the announcement, “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.” Dr. Shames is Professor and Chief, Division of Vascular Surgery at the University of South Florida Morsani School of Medicine in Tampa, Florida.
Additionally, Medtronic reported that its Valiant Navion left subclavian artery (LSA) branch thoracic stent graft system received FDA Breakthrough Device designation in May 2019 to allow for more timely delivery of treatment options for patients in need of LSA coverage during thoracic endovascular aortic repair.
Valiant Navion LSA is based on the Valiant Mona LSA investigational device and the FDA-approved Valiant Navion stent graft system. Like Valiant Navion, the off-the-shelf, single-branch device features a low-profile design that may further enable patient applicability and access. The branch cuff is intended to replicate the natural anatomy of the LSA to maximize seal and patency.
The company noted that 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.