Irving, Texas-based Novation is a group purchasing organization that serves more than 100,000 members and affiliates in the U.S., Lombard said, including VHA Inc., UHC, Children’s Hospital Assn. and Provista LLC.
"Based on a thorough review of its clinical evidence, a Novation member-led council determined that Aorfix meaningfully advances the treatment outcomes in patients with abdominal aortic aneurysms and granted its innovative technology designation to this device. We’re pleased to extend the benefits of this solution to the members we serve and who rely on Novation to provide access to the latest technologies that are clinically validated and cost-effective on contract," Novation senior clinical manager Olya Carter said in a prepared statement.
Aorfix is an endovascular stent designed to treat abdominal aortic aneurysms by creating an internal bypass of the aneurysm to reduce risk of rupture, the company said. The device is approved for indications in patients with neck angulations up to 90 degrees.
"Through this new agreement with Novation, we are able to offer more physicians in the U.S. the option to treat AAA patients with Aorfix. The designation of Innovative Technology reflects the excellent clinical outcomes demonstrated by Aorfix in the Pythagoras study and further supports our belief that Aorfix provides a safe, effective, on-label solution for a greater population of AAA patients than any other AAA stent graft," Lombard CEO Simon Hubbert said in a press release.
A post-market study of the device was launched in April this year, slated to enroll 234 patients over the next 5 years. Lombard took out a $26 million loan to use to fund the global roll-out of the Aorfix later that same month. The company won FDA approval for Aorfix in 2013.