Endologix ’s CE Mark for Nellix is Suspended

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.”   MD&M West is where serious professionals find the technologies, education, and connections to stay ahead in the global medical manufacturing community and will be in Anaheim, from Feb. 5-7.  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...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news