VALOR II 5-Year Data Presented for Medtronic's Valiant TEVAR System

October 5, 2015—Medtronic plc announced that 5-year data from the VALOR II study demonstrated the durability of the Valiant thoracic stent graft system in the treatment of thoracic aortic aneurysms (TAAs). VALOR II is a prospective, single-arm study that involved 160 patients at 24 United States medical centers. The trial was designed to evaluate the safety and effectiveness of the Valiant device for endovascular repair of aneurysms in the descending thoracic aorta.

According to the company, key 5-year follow-up findings from VALOR II include 94.8% freedom from aneurysm-related mortality; a 1.3% rupture rate; 6.9% required secondary procedures; a 0.6% (1/160) conversion to open surgery rate; 89.3% of patients had stable or decreased aneurysm size; 0% migration (defined as > 10 mm from the 1-month follow-up); and 0% loss of integrity.

Mark F. Conrad, MD, presented the data at the 42nd annual meeting of the New England Society for Vascular Surgery held October 2–4 in Newport, Rhode Island. In Medtronic’s press release, Dr. Conrad commented, “The 5-year results from VALOR II provide confidence to physicians treating patients with descending TAA in the durability and effectiveness of the Valiant thoracic stent graft system. The 5-year data demonstrates a high rate of freedom from aneurysm-related mortality and rare incidences of rupture or conversion to open surgery.” Dr. Conrad is Director of Clinical Research, Division of Vascular and Endovascular Surgery and Assistant Program Director, Division of Vascular and Endovascular Surgery at Massachusetts General Hospital in Boston, Massachusetts.

The Valiant thoracic stent graft system is indicated for the endovascular repair of all lesions of the descending thoracic aorta in patients who have appropriate anatomy, including iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories; nonaneurysmal aortic diameter in the range of 18 to 42 mm; and nonaneurysmal aortic proximal and distal neck lengths ≥ 20 mm, advised Medtronic.