FDA Approval for Aortic Securement System
Published date : 24 September 2012
Article date : 24 September 2012
News-medical.net reports that the FDA has approved a thoracic-length HeliFXTM Aortic Securement System, from medical device manufacturer, Aptus Endosystems. They say that it is similar to the original HeliFX system that was cleared in November 2011 and designed for treating abdominal aortic aneurysms.
The new system consists of a longer delivery device with additional tip configurations to bring the innovative helical EndoAnchorTM technology to the treatment of thoracic aortic aneurysms, enlarged and weakened section of the aorta, the main artery carrying blood from the heart.
Apparently, the implantable EndoAnchor enables independent endograft fixation and is designed to replicate the sealing and fixation of hand suturing performed during open surgical repair of aortic aneurysms. It can be used during de novo (initial) TEVAR procedures to enhance an endograft's inherent fixation and sealing mechanisms. Plus, the EndoAnchors can be used to repair endovascular grafts that have migrated away from the implant site and have developed endoleaks or are at risk of developing these complications.
Source: News-medical.net, 19 September 2012
Read the full article here.