FDA Sets November Date for Advisory Committee Meeting on Endologix AFX Endovascular Graft System

August 26, 2021—The FDA announced the dates and details for a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee regarding the Endologix AFX endovascular graft system. The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues, noted the FDA.

FDA intends to make background material available to the public no later than 2 business days before the meeting.

Background material and the link to the online teleconference meeting room will be available here, likely by late in the day on Friday, October 29.

The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

The FDA initially announced the intention of the meeting in December 2020. On March 29, 2021, the agency announced an update of its plans to hold the virtual 2-day meeting of the CDRH Circulatory System Devices Panel of the Medical Devices Advisory Committee in Q4 of 2021.

The announcement has now been published in the Federal Register, which provides all specific information about participation in the meeting and other details.

The meeting will take place virtually on November 2 and 3, 2021, from 9:00 am to 6:00 pm, Eastern Time. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. FDA noted that because of the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via the online teleconferencing platform.

On November 2, the committee will discuss and make recommendations on information about the benefit-risk profile of the Endologix AFX endovascular graft system with regards to the risk of type III endoleaks. FDA requests panel input regarding the totality of data collected on AFX devices and whether further actions are necessary.

On November 3, the committee will discuss and make recommendations on the continued safety and effectiveness of endovascular stent grafts and how to strengthen real-world data collection on long-term performance of the devices, both for currently marketed devices and for future technologies. FDA intends to request panel input on the clinical outcomes that are most relevant to capture in the real world, along with their frequency and duration. Additionally, FDA intends to seek input on data collection platforms, and how to incentivize and optimize real world data collection.