Endologix Gets EU OK for New System

Irvine, Calif.-based Endologix Inc. has been granted CE mark approval to market its new version of the Nellix endovascular aneurysm sealing (EVAS) system for the treatment of patients with abdominal aortic aneurysms (AAAs). The system’s previous incarnation received CE mark in October 2012; the enhancements were related to issues with limb patency that emerged just before European Union approval was granted the first time around. EVAS with Nellix is designed to simplify endovascular AAA procedures, treat a broad range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States for either investigational use or commercial sale.

Endologix expects to begin a limited market introduction of the Nellix System in Europe during the second quarter of 2013. The company will also initiate a post-market clinical study of the Nellix System beginning in the third quarter of 2013 in European centers.

“We are very excited to receive CE mark for the Nellix System, which will allow Endologix to introduce the world’s first AAA endovascular aneurysm sealing system, or EVAS, to physicians and patients in Europe,” said John McDermott, president and CEO. “We believe Nellix has the potential to simplify AAA procedures, treat a broad range of patients and improve clinical outcomes. The initial commercial activity for Nellix will begin in the second quarter 2013, with a focus on building the clinical experience in collaboration with thought-leading physicians. We will also begin a post-market clinical study, to gather additional data and patient follow-up to support gradual introductions in other markets. The physicians at the initial clinical sites will collect this data and also help us train other physicians as we gradually roll-out Nellix over the course of the year, with a broader launch anticipated in 2014.”

McDermott added that the company is “well positioned” in Europe with its AFX endovascular AAA system, and is expecting CE marking of its Ventana fenestrated system, an aortic extension intended to be used with AFX. Ventana has an investigation device exemption in the United States through the U.S. Food and Drug Administration.

“We have received strong interest in all of these products from the medical community and believe that Endologix offers physicians the most innovative range of products to treat their AAA patients,” said McDermott. “We look forward to providing training and clinical support for these and other new technologies in 2013 and the years ahead.”

Endologix develops and manufactures minimally invasive treatments for aortic disorders.