Clinical Outcomes
In over 20,000 Talent Thoracic Stent Graft implants worldwide, there were no reported collapses in the first 6 years.
Summary
Talent Thoracic Stent Graft
A Decade of Worldwide Experience
- No reported collapses in more than 20,000 implants worldwide in the first 6 years of experience1
- Discussed in more peer-reviewed publications than any other thoracic stent graft2
The Talent Thoracic Stent Graft has been commercially distributed worldwide for over ten years and has been sold within the United States since its approval on June 5, 2008. Worldwide over 13,800 patients (>25,000 devices) have been treated with the Talent Thoracic Stent Graft.
This device is intended to treat fusiform aneurysms and saccular aneurysms/penetrating ulcers of the descending thoracic aorta. Through available follow-up data at 4 years, a 96.3% freedom from Aneurysm-Related Mortality was achieved, with four (4) conversions and four (4) ruptures observed. Additionally, thirty (30) subjects underwent additional endovascular procedures. A review of the worldwide complaint data yields, twelve (12) reports of post implant ruptures, thirty-six (36) conversions, and seventy-six (76) aneurysm related deaths.
Pre-operative Angiogram
Post-Operative Angiogram
Images courtesy of Ronald Fairman, MD, Professor and Chief, Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania
| Talent Thoracic Stent: Pivotal Clinical Data 3,4,* | |
|---|---|
| Effectiveness | |
| Successful aneurysm treatment† | 89.2% |
| Successful vessel access and deployment‡ | 99.5% |
| Patency | 100% |
| Safety | |
| All-cause mortality | 16.1% |
| Aneurysm-related mortality | 3.1% |
| Aneurysm rupture | 0.5% |
Download Talent TAA Clinical Update (PDF, 650 KB)
Important Safety Information
The Talent Thoracic Stent Graft has been shown effective through 10 years of clinical use. Longer term data is required to examine the rate of adverse events including surgical conversion, aneurysm-related death, migration, and endoleak beyond this timeframe.
* The Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) is a prospective, nonrandomized, 3-armed, multicenter study conducted to evaluate the safety and effectiveness of the Talent Thoracic Stent Graft System when used in low-to-moderate risk patients with thoracic aortic disease (test arm n=195). The primary effectiveness endpoint is successful aneurysm treatment at 12 months. The primary safety endpoint is all-cause mortality at 12 months. Data in this chart is 12-month data unless otherwise noted.
† Successful aneurysm treatment is defined as no aneurysm growth >5 mm at 12-month follow-up when compared to 1-month follow-up visit and absence of a Type I endoleak for which a secondary procedure was performed before, at, or as a result of the 12-month follow-up visit. Of the 14 subjects with a primary effectiveness failure at 12 months, 10 patients had aneurysm growth > 5 mm, 3 patients had a Type I endoleak requiring reintervention, and 1 patient had both aneurysm growth > 5 mm and a Type I endoleak requiring reintervention.
‡ Successful deployment and delivery of the stent graft at implantation equaled 99.5%. This secondary endpoint is a 30-day endpoint.
References
- Medtronic Field Assurance Worldwide Complaints for Talent Thoracic on CoilTrac. January 2002-April 15, 2008 inclusive.
- Data on file. Medtronic Vascular; Santa Rosa, CA; 2008.
- Summary of Safety and Effectiveness Data – Talent Thoracic Stent Graft System.
- Kwolek CJ, Fairman R. Update on thoracic aortic endovascular grafting using the Medtronic Talent device. Semin Vasc Surg. 2006;19(1):25-31.