First Clinical Cases Performed Using Lombard Medical's Aorfix(TM) Plus Endovascular Stent Graft


Lombard Medical, Inc., a medical device company focused on Endovascular Aneurysm Repair (EVAR) of abdominal aortic aneurysms (AAAs), announced today that the first clinical cases using its 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 FDA, increasing the upper range of treatable aortic neck diameters up to 33mm. Up to 10 percent more patients with an 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 centers, including Loma Linda Veterans Administration Hospitalin Loma Linda, CA. One of the initial Aorfix Plus cases was performed by Dr.Randy Reisser, a vascular surgeon at Blount Memorial Hospital in Merryville, TN, who has performed several cases using the device. He stated, "I find the stent graft extremely easy to deploy making the placement very predictable." Dr. Reisser has used many commercially available stent grafts and 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, CEO 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 (PMA) study for Aorfix, we anticipate Aorfix Plus will enable us to treat up to 10 percent 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."

About Aorfix™ Endovascular Stent Graft 

Aorfix™ is an endovascular stent graft system for treating infra-renal aortic and aorto-iliac aneurysms, also known as abdominal aortic aneurysms (AAAs). When placed within the aneurysm, Aorfix creates an internal bypass of the aneurysm to reduce the risk of rupture. Aorfix is the first and only endovascular stent graft with global approvals for the treatment of patients with aortic neck angulations up to 90 degrees. Aorfix features an exclusive helical and circular design that allows it to conform to the natural contours of human anatomy, including aortic necks with high angulations and iliac arteries with extreme bends. Aorfix has been evaluated in three studies and used in more than 4,000 procedures worldwide. Aorfix received FDA approval in 2013, and is commercially available in U.S., U.K., Germany, Spain, Italy, Austria, Switzerland, the Czech Republic, Russia, Greece, Canada, Mexico, Brazil, Japan, Hong Kong, Poland, New Zealand, Argentina, Sweden, Colombia, Ireland, Chile, Peru, and Uruguay.

Source: Lombard Medical

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