It looks like more bad news for Endologix. The Irvine, CA-based company said its CE Mark for the Nellix EndoVascular Aneurysm Sealing System has been suspended by its Notified Body, GMED. Endologix first received approval in Europe for the device in 2013.
The Nellix system was developed as an alternative treatment to traditional endovascular aneurysm repair for an abdominal aortic aneurysm. The system is designed to seal an entire aneurysm.
“The notification from GMED is a regulatory action and is not in response to any new information beyond our recent FSN,” Dr. Matt Thompson, CMO of Endologix, said in a release. “This action is consistent with our previously articulated plans for the Nellix System and does not affect other Endologix products. We remain steadfast in our commitment to patient safety and believe in the transformational potential of Nellix.”
The suspension of the CE mark comes on the heels of Endologix initiating a voluntary recall of existing inventory for the Nellix system.
Endologix has also been struggling with the product over the past few years and has had several commercialization delays in the U.S.
The company was originally on track to have FDA approval of the device by the end of 2016. However, that goal came to a screeching halt about midway through that year at its 100-day meeting with FDA.
It was at that meeting that the agency first brought up the possibility of requiring an advisory committee panel meeting due to the novelty of the device.
The agency also requested clinical data on the latest version of the Nellix system, which was already available in Europe, leading management to chart a new course and pursue approval for an earlier version of the system that was studied in an earlier investigational device exemption trial. That would have delayed approval by just two or three quarters, but the timeline shifted again in February 2017 when Endologix said it would meet with FDA to discuss newly proposed instructions for use (IFU) to address potential device migration in patients with large amounts of thrombus and present two-year IDE data for the first generation of the device.
During a 2017 conference call, Endologix leadership announced FDA wanted to see prospective data for Nellix, thus leading to another delay in U.S. commercialization.