FDA Approves Endologix’s PMA Supplement for AFX2 System

Endologix LLC has received U.S. Food and Drug Administration (FDA) approval for a pre-market approval (PMA) supplement relating to the AFX2 System.
 
Endologix received approval to include an updated warning and the most contemporary clinical information in the labeling for the AFX2 System. Clinical data added to the Instructions For Use (IFU) includes: final results from the five-year LEOPARD randomized controlled trial, and results from the recently published, independently performed, VQI-VISION analysis on AAA endografts (Use of linked registry claims data for long term surveillance of devices after endovascular abdominal aortic aneurysm repair: observational surveillance study, Goodney, Philip, et al. British Medical Journal, 2022;397:e071452).
 
In both reported studies, out to three years, the rates shown for rupture and re-intervention are comparable between the AFX/AFX2 device cohort and endovascular aneurysm repair (EVAR) comparator devices. Additionally, results from the LEOPARD study demonstrated no significant difference in aneurysm-related mortality, all-cause mortality, rupture, secondary interventions, and Type I and Type III endoleaks between the AFX/ AFX2 device cohort and the EVAR comparator devices.
 
Endologix LLC is a global medical device company that develops and provides therapies for the interventional treatment of vascular disease. Endologix’s therapeutic portfolio includes a variety of products in various stages of development that are designed to treat diseases that currently have clinically relevant unmet needs. These products are designed to treat a wide spectrum of vascular disease from abdominal aortic aneurysms to lower limb peripheral vascular disease. Endologix’s current commercial EVAR products include the AFX 2 Endovascular AAA System and the ALTO Abdominal Stent Graft System. On Oct. 1, 2020, Endologix became a private company, wholly owned by Deerfield Management, an investment management firm committed to advancing healthcare through investment, information, and philanthropy. In April 2021, Endologix completed the acquisition of PQ Bypass Inc., a privately held medical technology company, adding the DETOUR System and TORUS Stent Graft to the company’s product pipeline. The DETOUR System and the TORUS Stent Graft have not been approved for sale by any regulatory body. The DETOUR System is an investigational device, limited by United States law to investigational use.
 
The company has offices and manufacturing sites in Irvine and Santa Rosa, Calif.