Nellix

Nellix, Inc. was a privately-held medical device company based in Palo Alto, California, that developed a treatment for Abdominal Aortic Aneurysms (AAAs). In October 2010, Endologix, Inc., a company focused on minimally invasive aortic disorder treatments, announced its acquisition of Nellix. The deal involved an initial $15 million in stock, with up to $39 million in additional milestone-based payments. The acquisition was finalized in December 2010. The President and CEO of Nellix at the time of the acquisition was Bob Mitchell.

The company's core product was the Nellix® EndoVascular Aneurysm Sealing (EVAS) System. This system represented a different approach compared to traditional Endovascular Aneurysm Repair (EVAR). Instead of just excluding the aneurysm sac from blood flow with a stent-graft, the EVAS system was designed to completely seal the aneurysm sac. The device consists of two balloon-expandable stents, each enclosed in a non-porous endobag. During the procedure, these are placed at the site of the aneurysm and then filled with a biocompatible polymer, which conforms to the shape of the aneurysm sac, effectively obliterating it. This method aimed to reduce complications like device migration and endoleaks, which can occur with conventional EVAR devices.

The Nellix system was targeted at vascular surgeons treating patients with infrarenal AAAs. The business model centered on the development and sale of this single-use, implantable medical device. Following its acquisition by Endologix, the strategy included building a direct sales force in Europe to facilitate a commercial launch. The device received a CE Mark in Europe, allowing for its commercial use in that market, and was also available in New Zealand. However, in the United States, the Nellix system remained an investigational device, meaning it was not approved by the Food and Drug Administration (FDA) for general commercial use and could only be used in clinical trials. Endologix pursued FDA approval through various Investigational Device Exemption (IDE) studies over several years. In early 2019, Endologix initiated a voluntary recall of the existing inventory of the Nellix system due to concerns about suboptimal outcomes when the device was used outside of its specific instructions for use. Following the recall, the device was only made available under strict clinical protocols for pre-screened patients.

Keywords: Nellix, Endologix, endovascular aneurysm sealing, EVAS, abdominal aortic aneurysm, AAA repair, medical device, endograft, aneurysm sac sealing, vascular surgery, minimally invasive, polymer-filled endobags, stent-graft, endoleak prevention, device migration, CE Mark, investigational device, IDE trial, Bob Mitchell, endovascular therapy