The Medicines and Healthcare products Regulatory Agency (MHRA) has released significant updates regarding the management of patients who previously received the Endologix Nellix EndoVascular Aneurysm Sealing (EVAS) System—a device subject to recall. As of September 30, 2025, the guidance reflects updated recommendations tailored to ensure patient safety and optimal care. This announcement is crucial for clinical, quality, and regulatory professionals tasked with monitoring affected patients and aligning practices with the revised guidance.
What changed?
This latest MHRA guidance supersedes previous recommendations by integrating newly evaluated data and clinical insights concerning the Nellix EVAS System, which was recalled due to safety and performance concerns. The update prioritizes a refined approach to patient monitoring and management, emphasizing the identification and mitigation of any adverse events associated with the device.
Who is affected?
The guidance pertains to all patients in the UK who had the Endologix Nellix EVAS System implanted prior to its recall. Healthcare professionals managing these patients must carefully assess relevant clinical profiles and adhere to the updated recommendations to ensure compliance and the highest standard of care.
Updated management strategies
Ensuring proactive monitoring
Healthcare teams are advised to maintain regular, proactive surveillance of patients with the recalled device, focusing on diagnostic imaging and clinical examinations to identify potential complications early.
Reporting adverse events
Clinicians must report any device-related issues or adverse events via established regulatory pathways, ensuring timely intervention and alignment with MHRA protocols.
Collaboration across teams
Multidisciplinary collaboration between clinical, regulatory, and quality teams is recommended to streamline patient care and ensure adherence to updated recommendations. This includes revisiting risk stratification criteria and management pathways.
Frequently Asked Questions
- Why was the Endologix Nellix EVAS System recalled?
The device was recalled due to concerns over its long-term safety and performance in treating patients with abdominal aortic aneurysms. - What should healthcare providers prioritize?
Providers should focus on regular monitoring, reporting adverse events, and adhering to MHRA recommendations. - Are there alternative treatments available?
Yes, alternative devices and techniques for aneurysm management are available, and decisions should be made based on individual patient cases.
Key takeaways
This update underscores the importance of vigilance in managing patients with the recalled Nellix EVAS System. By adhering to MHRA’s revised guidance, healthcare professionals can better safeguard patient outcomes and regulatory compliance. Teams should review protocols immediately and ensure all affected patients are monitored under the updated recommendations.
Disclaimer
This content is intended for healthcare and regulatory professionals. It does not constitute legal or medical advice. Refer to official MHRA documents for complete guidance.
Official announcement link
For full information about the announcement, see the link below.