Endologix (NSDQ:ELGX) said it won FDA premarket approval for its AFX2 bifurcated endograft system for treating abdominal aortic aneurysms.
The system is the newest-generation of AFX endovascular AAA product from the Irvine, Calif.-based company. The new version of the device reduces delivery and deployment procedure steps and can facilitate percutaneous endovascular aneurysm repair through a low-profile 7F introducer.
“The AFX system is already uniquely positioned as the only anatomical fixation EVAR device on the market. With the approval of AFX2, we have taken a versatile platform and combined it with an easy to use, low profile delivery system. We believe this will enable more physicians to utilize AFX2 and offer its unique clinical benefits to patients. We’d like to thank all the physicians who provided input into the new design and look forward to introducing AFX2 early in 2016,” CEO John McDermott said in a press release.
Endologix said it plans to present the product at the VEITH Symposium conference in New York City next month, with a commercial rollout slated for early 2016.
In May, the company said data from a pivotal trial of its Nellix system for treating abdominal aortic aneurysms met its primary safety endpoint, reporting endoleaks in 9 patients.
Endologix said the 150-patient trial showed a 100% procedural success rate with no device-related adverse events, aneurysm ruptures, conversions, limb thromboses, stent fractures or kinking after 30 days.