Clinical Outcomes
Safety and effectiveness of the Talent abdominal stent graft – 5-year results.
Summary
The Talent® Abdominal Stent Graft System has been commercially distributed worldwide for over 10 years and has been sold within the United States since its approval on April 15, 2008. The 5-year results from the US IDE clinical data support the safety and effectiveness of the Talent abdominal stent graft when used to treat abdominal aortic aneurysms. Through 5 years, a 96.5% freedom from aneurysm-related mortality, a 98.2% freedom from rupture, and a 99.1% freedom from conversion were achieved.
| Talent Abdominal 5-Year PMA Outcomes | At 5 Years |
|---|---|
| Freedom from Aneurysm-Related Mortality | 96.5% |
| Freedom from Rupture | 98.2% |
| Freedom from Conversion | 99.1% |
| Migration | 2.3% |
| Limb Thrombosis | 0% |
| Limb Kinking | 0% |
| Rate of Secondary Procedures | 0% |
IMPORTANT
The Talent Abdominal Stent Graft System has been shown to be safe and effective through over 10 years of clinical data. Longer term data is required to examine the rate of adverse events including surgical conversion, aneurysm-related death, migration and endoleak beyond this time frame.