The trial, which launched in 2015, has since enrolled 458 patients. The study’s primary endpoint is freedom from aneurysm-related complications, including aneurysm rupture, conversion to open repair and endoleaks.
Freedom from ARC with AFX or AFX2 is 84.7%, compared to 82% for patients treated with other devices, based on data from patients who have reached their one-year follow-up.
The company said it plans to stop further randomization in its Leopard trial and continue to follow enrolled patients for five years.
“The results from this analysis are very encouraging. In particular, we are pleased with the trend towards lower rates of endoleaks, limb occlusions and secondary interventions with AFX/AFX2, along with the absence of Type 3 endoleaks,” CEO John McDermott said in prepared remarks. “We’d like to thank our investigators for participating in this important clinical study and look forward to presenting the final one-year results next year after all patients have completed their follow-up.”
Endologix shares fell over 10% earlier this month after the medical device maker missed expectations on Wall Street with its 2nd quarter earnings results.
The Irvine, Calif.-based company posted losses of $16.3 million, or 20¢ per share, on sales of $48.6 million for the 3 months ended June 30, seeing losses shrink 75.6% while sales shrunk 4.7% compared with the same period during the previous year.
Losses per share were higher than the 18¢ losses per share consensus on Wall Street, where analysts were expecting to see revenues of $47.6 million.