Medtronic’s Valiant Thoracic Stent Graft System has showed safety and efficacy in the treatment of thoracic endovascular aortic aneurysms, according to the company’s US pivotal prospective, single-arm study - VALOR II.
The VALOR II study, which involved 160 patients at 24 US medical centers, has met primary safety and effectiveness endpoints.
Principal investigator of the study Ronald Fairman said the VALOR II 12-month results demonstrate that the Medtronic Valiant stent graft is a safe and effective treatment for patients with descending TAA of degenerative etiology
"Through 12 months, there were no cases of rupture or conversion to open surgery. Overall, treatment results were quite promising," Fairman said.
The system is indicated for the endovascular repair of fusiform aneurysms, saccular aneurysms and penetrating ulcers of the descending thoracic aorta in patients having appropriate anatomy, including: iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories, non-aneurysmal aortic diameter in the range of 18-42 mm and non-aneurysmal aortic proximal and distal neck lengths = 20 mm.