FDA Approves Endologix System for PEVAR Indication

April 16, 2013—Endologix (Irvine, CA) announced that it has received US Food and Drug Administration (FDA) approval of its premarket approval supplement for a broadened indication for the company's 21-F profile and smaller endovascular aneurysm repair (EVAR) systems to include totally percutaneous EVAR (PEVAR) based upon the outcomes of the first prospective, multicenter, randomized clinical PEVAR trial.

According to the company's press release, the Endologix EVAR platforms include the Powerlink with IntuiTrak system and the AFX endovascular abdominal aortic aneurysm system, which are commercially available endografts to achieve the totally percutaneous labeling expansion facilitated using the Perclose ProGlide suture-mediated closure system (Abbott Vascular, Santa Clara, CA). The company stated that it expects to begin training physicians on the PEVAR procedure in the United States in the second quarter of 2013.

Endologix stated that the FDA approval provides a clinical validation of PEVAR in a multicenter setting using the company's fully integrated, sheath-based EVAR systems that also have contralateral standard percutaneous (9-F) indication.

The company noted that the PEVAR trial results were presented at recent meetings. The PEVAR investigators found significant benefits after PEVAR compared to surgical vascular access EVAR. Percutaneous EVAR procedures were completed in 34 fewer minutes, 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.

Endologix announced the presentation of the primary analysis of the PEVAR trial data by Peter R. Nelson, MD, at the 37th annual meeting of the Southern Association for Vascular Surgery. Zvonimir Krajcer, MD, presented a substudy at ISET 2013: the 25th annual International Symposium on Endovascular Therapy.