Endologix launches a clinical trial after landing FDA Investigational Device Exemption for the Nellix endovascular aneurysm sealing system.
Endologix (NSDQ:ELGX) said it won FDA Investigational Device Exemption for its Nellix endovascular aneurysm sealing system, paving the way for a U.S. clinical trial.
The EVAS Forward-IDE study is expected to enroll 180 patients at 30 sites throughout the U.S., Canada, and Europe. Researchers will test the safety and effectiveness of the Nellix device for endovascular repair of infrarenal abdominal aortic aneurysms.