The Aorfix Plus, designed to treat larger-size AAAs, won 510(k) clearance from the FDA for the device in February.
Irvine, Calif.-based Lombard said the 1st clinical cases using the device were successfully completed at sites including the Loma Linda Veterans Administration Hospital in California and Blount Memorial Hospital in Merryville, Tenn.
“I find the stent graft extremely easy to deploy making the placement very predictable,” Blount Memorial’s Dr.Randy Reisser said in prepared remarks, noting that “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,” added CEO Simon Hubbert. “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.”