September 19, 2016
Three-Year Data Presented for Medtronic's Valiant Captivia to Treat Acute Complicated Type B Aortic Dissections
September 20, 2016—Medtronic plc announced new data demonstrating safety and efficacy at 3 years in patients with acute complicated type B aortic dissection treated with the Valiant Captivia thoracic stent graft system. Ali Azizzadeh, MD, presented the new clinical data in a late-breaking trial session at VIVA 16, the Vascular InterVentional Advances annual conference in Las Vegas, Nevada.
In the company’s announcement, Dr. Azizzadeh commented, “Evidence shows that patients with acute complicated type B aortic dissections can be safely and effectively treated with thoracic endovascular aortic repair. The Valiant Captivia system continues to produce positive outcomes through 3 years in a very challenging patient population.” Dr. Azizzadeh is from the University of Texas Health Science Center in Houston, Texas.
As summarized by the company, the data were gathered on 50 patients in the Medtronic Valiant Captivia Dissection Investigational Device Exemption Trial that was conducted at 16 sites in the United States.
Through 3-year follow-up, the data showed that freedom from all-cause mortality was 79.4% and freedom from dissection-related mortality was 90%. There were no ruptures or conversions after the index procedure. True-lumen diameter over the stented region remained stable or increased in 92.3%, false-lumen diameter remained stable or decreased in 69.2%, and the false lumen was partially or completely thrombosed in 75% of patients. Three patients required secondary endovascular procedures related to the dissection, reported Medtronic.