Trial Results Prompt Expanded Indications for Endologix EVAR Systems

The U.S. Food and Drug Administration has approved a broader indication for Irvine, Calif.-based Endologix Inc.’s 21Fr profile and smaller endovascular aneurysm repair (EVAR) systems to include totally percutaneous endovascular aneurysm repair (PEVAR) based upon the outcomes of the first PEVAR trial.

The Endologix EVAR platforms include the Powerlink with Intuitrak system and the AFX endovascular AAA (abdominal aortic aneurysm) system, which, according to the company, are the only commercially available endografts to achieve the totally percutaneous labeling expansion by using the Perclose Proglide suture-mediated closure system made by healthcare company Abbott. Endologix expects to begin training physicians in the United States on the PEVAR procedure in the second quarter 2013.

The PEVAR trial results reportedly showed significant benefits following PEVAR compared to surgical vascular access EVAR. PEVAR procedures were completed in 34 minutes less time, required eight times fewer concomitant iliac/femoral artery procedures or repairs, and resulted in femoral artery hemostasis (stoppage of blood flow) in 57 percent less time. Other positive trends favoring PEVAR included reduced blood loss with 72 percent fewer patients requiring a blood transfusion, 2.5 times fewer patients with a serious adverse event, nearly 50 percent fewer patients needing analgesics or narcotics for groin pain, and discharge from the hospital half a day earlier.

“We are now the first and only company to receive a percutaneous indication for EVAR, which will allow us to begin training physicians on the PEVAR procedure using our unique platform of EVAR systems,” said John McDermott, chairman, president and CEO of Endologix. “We believe physicians and hospitals will be attracted to PEVAR because it is a less invasive procedure that has the potential to significantly reduce procedure times and improve the patient experience. We expect to begin PEVAR training courses in the second quarter, which will lead to a gradual increase in the number of percutaneous cases performed as we progress through the year.”

Endologix makes minimally invasive treatments for aortic disorders, focusing on endovascular stent grafts to treat AAAs.