Three year data on Valiant Captivia Thoracic Stent Graft System shows safety and efficacy in Type B aortic dissection- Medtronic

Medtronic announced new data, demonstrating safety and efficacy at three years in acute complicated Type B aortic dissection patients treated with the Valiant Captivia Thoracic Stent Graft System. The FDA-approved Valiant Captivia System demonstrates continued safety and efficacy at three years. The data were gathered on 50 patients in the Medtronic Valiant Captivia Dissection IDE Trial, conducted at 16 U.S. sites.

Data highlights through three-year follow-up include the fact that freedom from all-cause mortality was 79.4 percent and freedom from dissection-related mortality was 90.0 percent. There were no post-index procedure ruptures or conversions and true-lumen diameter over the stented region remained stable or increased in 92.3 percent, false-lumen diameter remained stable or decreased in 69.2 percent, and the false lumen was partially or completely thrombosed in 75.0 percent of patients. Three patients required secondary endovascular procedures related to the dissection. Data were presented at Vascular Interventional Advances (VIVA) 2016.

Comment: An acute aortic dissection is a serious condition in which the inner layer of the aorta tears, blood surges through the tear, and causes the inner and middle layers of the aorta to separate. This can result in aorta rupture or malperfusion of the vessels originating from the dissected aorta, leading to high morbidity and mortality. A type B dissection is a tear located in the descending aorta.