A new post-market clinical follow-up (PMCF) registry has been announced to assess the safety and performance of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft). The registry is sponsored by W.L. Gore & Associates and targets a range of vascular conditions. This study is not yet recruiting, and medical professionals in vascular intervention, regulatory teams, and device development specialists should take note.
In this article:
What is the objective?
The primary aim of this registry is to gather observational clinical data on the performance and safety of the Reduced Profile VBX Stent Graft in real-world applications. This device is specifically designed to meet the needs of patients with aorto-iliac occlusive disease (AIOD), visceral artery occlusive disease (VAOD), isolated artery aneurysms (IAA), and those with trauma or iatrogenic vessel injury.
This initiative aligns with post-market surveillance requirements under current medical device regulations. It is a critical step for W.L. Gore & Associates in their commitment to ensuring long-term device efficacy and patient safety.
Who is affected?
The registry will focus on patients requiring vascular interventions for complex conditions. The study’s scope encompasses:
- Aorto-iliac occlusive disease (AIOD)
- Visceral artery occlusive disease (VAOD)
- Isolated artery aneurysms (IAA)
- Trauma or iatrogenic vessel injury
Clinicians specializing in vascular surgery and interventional radiology, along with regulatory experts monitoring device compliance in clinical scenarios, are key stakeholders. Hospitals and research centers equipped to take part in advanced vascular interventions may also find opportunities to contribute to this study.
Study details
The study is an observational PMCF registry designed to monitor the performance of the Reduced Profile VBX Stent Graft. While it is currently not yet recruiting, the registry will prioritize thorough and systematic post-market data collection.
The Reduced Profile VBX Stent Graft has been designed with a focus on minimizing device profile for easier navigation through challenging anatomies. This enhancement addresses historical challenges in treating complex arterial conditions.
W.L. Gore & Associates is sponsoring this registry to consistently align with regulatory standards for post-market surveillance and enhance device visibility among clinical, scientific, and regulatory audiences.
FAQs
1. What is the Reduced Profile VBX Stent Graft used for?
This device is intended for use in treating vascular conditions such as AIOD, VAOD, isolated artery aneurysms, and vessel injury from trauma or medical interventions.
2. When does recruitment for the study begin?
No specific dates have been announced yet, as the registry is currently listed as not recruiting.
3. Who sponsors this registry?
The registry is sponsored by W.L. Gore & Associates, a notable manufacturer of advanced vascular devices.
Conclusion
The announcement of this registry marks a significant step in post-market surveillance of the GORE® VIABAHN® VBX Stent Graft. With its focus on real-world data collection, the initiative aims to strengthen the understanding of the device’s efficacy and safety across various complex vascular conditions. Regulatory professionals, clinicians, and stakeholders should monitor further updates on this registry as it progresses towards recruitment and completion.
Disclaimer
This article is for informational purposes. It does not constitute legal advice or a substitute for professional medical or regulatory consultation. Stakeholders should consult the original study record or their regulatory authority for further guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07279649?term=medical+device