Endologix (Irvine, CA) received an Investigational Device Exemption (IDE) from the FDA to initiate a clinical study to prove the safety and effectiveness of the Nellix Endovascular Aneurysm Sealing System. The clinical study, called EVAS FORWARD-IDE, which will enroll 180 patients at 30 locations in the US, Europe, and Canada, is part of the larger EVAS FORWARD Clinical Program that aims to provide clinical and economic evidence for the Nellix Endovascular Aneurysm Sealing device.
The Nellix device, intended to treat infrarenal abdominal aortic aneurysms (AAA), was engineered as an alternative to endovascular stent grafts in order to treat a wider range of anatomies. The device works on the principle of sealing the aneurysm sac rather than providing a protective conduit through the aneurysm like a stent graft would, and is designed to minimize implant migration, eliminate endoleaks, and preserve patency internal iliac arteries.
The device has two main parts: bilateral stents that pave the blood from the infrarenal segments to legs, and endobags that are inflated with a biostable polymer to seal the aneurysm sac. According to Endologix, some of the inclusion criteria for patients to be enrolled in the EVAS FORWARD-IDE clinical study are as follows:
- Non-aneurysmal aortic neck length of ≥ 10mm
- Non-aneurysmal aortic neck diameter of 18 to 32mm
- Maximum aortic blood flow lumen diameter of ≤ 60mm
- Common iliac artery diameter of 8 to 35mm
In investigational cases performed in Europe, the Nellix device has shown excellent anatomic fixation at the aortic bifurcation and optimal stability of the filled endobags for the entire length of the device. The device received European CE mark approval in September 2012. Recently the device got FDA approval.