A medical device used in the minimally invasive treatment of thoracic aortic aneurysms, the Valiant Thoracic Stent Graft System (Medtronic), delivered excellent clinical results through one year of patient follow-up in the company’s US pivotal study, VALOR II, according to data presented at the Society for Vascular Surgery Annual Meeting in Chicago, USA.
One-year results of the VALOR II study were presented during a late-breaking clinical trials session by principal investigator Ronald Fairman, Clyde F Barker – William Maul Measey Professor of Surgery at the Hospital of the University of Pennsylvania, where he is chief of the division of vascular surgery and endovascular therapy, and the department of surgery’s vice-chairman of clinical affairs.
“The VALOR II 12-month results demonstrate that the Medtronic Valiant stent graft is a safe and effective treatment for patients with descending thoracic aortic aneurysms of degenerative etiology,” Fairman concluded. “Through 12 months, there were no cases of rupture or conversion to open surgery. Overall, treatment results were quite promising.”
VALOR II is a prospective, single-arm study that involved 160 patients at 24 US medical centres. It was designed to evaluate the safety and effectiveness of the Valiant Thoracic Stent Graft System for thoracic endovascular aortic repair (TEVAR) of aneurysms in the descending thoracic aorta.
The study met all of its prespecified endpoints. The primary safety and effectiveness endpoints were 12-month all-cause mortality and 12-month successful aneurysm treatment, defined as the absence of (a) aneurysm growth (>5mm) at one and 12 months, and (b) type I and/or type III endoleak for which a secondary procedure was performed or recommended at or before the 12-month visit.
Through one-year of follow-up in VALOR II, the rate of all-cause mortality was 12.6%, with only 3.3% of mortalities deemed aneurysm-related. Nearly all patients (97.4%) achieved 12-month successful aneurysm treatment, and very few stent grafts (2.9%) migrated from their original placement.
The Valiant Thoracic Stent Graft 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 18–42mm and non-aneurysmal aortic proximal and distal neck lengths ≥20mm.