đź“Š Evidence-Based Reference
talent thoracic stent graft system with the xcelerant and captiva delivery system
Medtronic Vascular
Summary: The Talent Thoracic Stent Graft System by Medtronic Vascular is designed for thoracic endovascular aneurysm repair (TEVAR). Key evidence shows superior outcomes compared to open surgical repair in certain patient populations.
FDA Clearance Information
Pathway
PMA
Number
P070007 ↗
Decision Date
August 16, 2012
Product Code
MIH
Device Class
Class 3
Evidence
0 studies
The Talent Thoracic Stent Graft System received FDA premarket approval (PMA) on August 16, 2012. It is manufactured by Medtronic Vascular and classified as a Class III medical device.
What It Is
The Talent Thoracic Stent Graft System is an endovascular device used for the repair of thoracic aortic aneurysms. It is designed to be delivered via a catheter-based system, allowing for minimally invasive treatment of aneurysms in the thoracic aorta.
Clinical Applications
This device is commonly used in patients with descending thoracic aortic aneurysms, particularly those who are at low or moderate risk for open surgical repair. It provides a less invasive alternative to traditional surgery.
Evidence Summary
The available literature includes 12 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2010 to 2012 and involve a significant number of patients.
Reported Outcomes
Published studies report that the Talent Thoracic Stent Graft System demonstrates superior 30-day and 1-year outcomes compared to open surgical repair in patients with descending thoracic aneurysms. The VALOR trial highlighted its effectiveness in low to moderate-risk patients, with favorable long-term results.
Safety Profile
Reported complications include misaligned deployment due to high flow rates and severe aortic angulation. Studies have discussed techniques to predict and avoid these complications, emphasizing the importance of careful deployment.
Evidence Limitations
Evidence gaps include the need for longer-term follow-up studies to assess durability and performance over time. Additionally, further research is needed to evaluate outcomes in diverse patient populations and complex anatomical scenarios.
Frequently Asked Questions
What are the clinical indications for Talent Thoracic Stent Graft System?
The device is indicated for the repair of descending thoracic aortic aneurysms, particularly in patients at low or moderate risk for open surgical repair.
What outcomes have been reported in clinical studies?
Clinical studies have reported superior 30-day and 1-year outcomes compared to open surgical repair, with favorable long-term results in low to moderate-risk patients.
What complications have been reported?
Reported complications include misaligned deployment due to high flow rates and severe aortic angulation, with techniques available to mitigate these risks.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.