GMED Reinstates CE Mark for Endologix Nellix System

Endologix reported a huge regulatory win this week. The Irvine, CA-based company said its CE mark for the Nellix EndoVascular Aneurysm Sealing System has been reinstated, allowing the device to return to the European market. In January, Endologix initiated a voluntary recall of the existing inventory of its Nellix endovascular aneurysm sealing system. The company decided to limit the device to use under clinical protocol with pre-screened patients that adhere to the current indications. The company's CE mark for the Nellix system was subsequently suspended. Endologix said the reinstatement followed an assessment of clinical evidence. “We continue to believe that the Nellix system has the potential to transform the treatment of patients with infra-renal abdominal aortic aneurysms,” said Matt Thompson, MD, chief medical officer at Endologix. “This therapy continues to generate positive results when used in patients that conform to the anatomical indications for use. We are delighted that the available data supports the reinstatement of our CE mark, and we look forward to utilizing this technology to improve the patient experience and drive better outcomes.” The company said the Nellix will be available at approved centers in a post-market clinical investigational setting outside the United States. The device is not yet approved for the U.S. market,...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news