The first clinical cases using Lombard Medical’s new Aorfix Plus endovascular stent graft have been successfully completed.
The new addition to the Aorfix endovascular stent graft portfolio was recently approved by the US Food and Drug Administration (FDA), increasing the upper range of treatable aortic neck diameters up to 33mm. Up to 10% more patients with an abdominal aortic aneurysm (AAA) have the potential to be treated with the Aorfix device as a result of the expanded size range. Aorfix is the only endovascular stent graft with global regulatory approvals for the treatment of patients with aortic neck angulations up to 90 degrees, often a feature of complex AAA anatomies.
The first cases were successfully completed at a number of centres, including Loma Linda Veterans Administration Hospitalin Loma Linda, USA. One of the initial Aorfix Plus cases was performed by Randy Reisser, a vascular surgeon at Blount Memorial Hospital in Merryville, USA, who has performed several cases using the device. He stated, “I find the stent graft extremely easy to deploy making the placement very predictable.” Reisser believes “the Aorfix stent graft works very well as compared to other devices and its broader size range now available will allow surgeons to deploy the device in a greater patient pool.”
“The launch of the Aorfix Plus stent graft further expands our ability to treat a wider range of patients,” said Simon Hubbert, chief executive officer of Lombard Medical. “Our aim is to provide the most effective on-label solution for the broadest AAA patient population—this clearance gets us closer to that goal. Based on patient data collected while conducting the premarket approval study for Aorfix, we anticipate Aorfix Plus will enable us to treat up to 10% more patients with our family of devices. Aorfix’s unique indication to treat patients with aortic neck angulations up to 90 degrees, coupled with a comprehensive suite of sizing options, will allow an even greater number of patients with AAAs to benefit from treatment with Aorfix.”