Broadened Indication for 21Fr Profile, Smaller EVAR Systems

Officials from medical device manufacturer Endologix Inc. announce that the company has received U.S. Food and Drug Administration (FDA) approval of its premarket approval (PMA) supplement for a broadened indication for the company's the 21Fr profile and smaller EVAR systems - to include totally percutaneous endovascular aneurysm repair (PEVAR) based upon the outcomes of the first prospective, multicenter, randomized clinical trial (The PEVAR Trial).

The Endologix EVAR platforms include the Powerlink with IntuiTrak System and the AFX Endovascular AAA System, which are the first and only among commercially available endografts to achieve the totally percutaneous labeling expansion facilitated using the Perclose ProGlide Suture-Mediated Closure System made by healthcare company Abbott. The company expects to begin training physicians in the U.S. on the PEVAR procedure in the second quarter 2013.

The FDA approval provides the first clinical validation of PEVAR in a multicenter setting using the company's fully integrated, sheath-based EVAR systems that already had the industry's only contralateral standard percutaneous (9Fr) indication. The trial results, presented at recent medical meetings, found 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 achievement of femoral artery hemostasis in 57% less time. Other positive trends favoring PEVAR included reduced blood loss with 72% fewer patients requiring a blood transfusion, 2.5 times fewer patients with a serious adverse event, nearly 50% fewer patients needing analgesics or narcotics for groin pain, and discharge from the hospital 0.5 days earlier.

John McDermott, chairman, president, and CEO, Endologix, says, "We are pleased to receive FDA approval for our PEVAR indication, which provides our sales force with another unique AAA technology to offer our customers. 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. 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."