Endologix (Irvine, CA) has announced that European regulators gave the go-ahead to launch the Nellix EndoVascular Aneurysm Sealing System on the continent. It is designed to virtually seal the aortic aneurysm sac to relieve any pressure on the fragile artery as blood bypasses through the device.
Though the company is glad of the current approval, it plans on submitting application for a slightly improved version of the Nellix with the hope of making it available to physicians in Europe in the 2nd quarter of next year.
Here are the requirements that were used to select patients for clinical trials of the Nellix:
- Non-aneurysmal aortic neck length of ≥ 5mm
- Non-aneurysmal aortic neck diameter of 16 to 36mm
- Maximum aortic blood flow lumen diameter of ≤ 60mm
- Common iliac artery diameter of 8 to 35mm
Some details on the clinical trials performed using the Nellix from the product page:
In initial clinical trial experience involving 34 patients outside of the United States (Krievins DK, et al., EVAR using the Nellix Sac-anchoring Endoprosthesis: Treatment of Favourable and Adverse Anatomy, EUR J Vasc Endovasc Surg (2011), doi: 10.1016/j.ejvs.2011.03.007), 100% implant success was observed. To two year follow-up, no aneurysm rupture, conversion to open surgery or stent graft migration has been observed. One secondary procedure for distal Type I endoleak has been performed (2.9% of patients). Physician feedback has been positive, particularly as it relates to ease of use and versatility to treat both standard and more challenging aneurysm anatomies.
Product page: Nellix…