Endologix launches study of second-gen Nellix endovascular aneurysm sealing system

Endologix (NSDQ:ELGX) said today that the first patient was treated in a study of its Nellix endovascular aneurysm sealing system.

The company’s Nellix system, designed to seal a patient’s entire aneurysm, is being developed as an alternative to traditional EVAR devices. Endologix’s system has CE Mark clearance in the European Union and is sold in a number of markets around the world.

The first patient in the company’s confirmatory IDE study was treated by Dr. Sajjad Hussain at St. Vincent Heart Center in Indiana. The EVAS2 trial is slated to enroll up to 90 patients and follow their progress over the course of one year. The company said that it plans to use the trial’s results to assess the safety and efficacy of the second-generation Nellix system and refine the product’s indications.

“We are excited to be part of this important trial studying the concept of total aneurysm sealing,” principal investigator Dr. Jeffrey Carpenter said in prepared remarks. “The second-generation Nellix device, together with the refined IFU and our clinical learnings over the past few years, has the potential to improve outcomes for patients with abdominal aortic aneurysms.”

“We would like to congratulate Dr. Hussain and the clinical study team at St. Vincent Hospital for completing the first EVAS2 procedure in the confirmatory study,” CEO John McDermott added. “We look forward to collaborating with all of our investigators to achieve excellent clinical outcomes for patients and to complete enrollment in the study. Based on anticipated enrollment, follow-up, and typical regulatory review timelines, we continue to estimate a decision on our PMA by the end of 2020.”

In May last year, ELGX shares dropped more than -30% after the company revealed that meetings with the FDA and internal analysis led it to decide to launch EVAS2. The U.S. safety watchdog first asked Endologix for more follow-up data from the company’s study of Nellix in Nov. 2016.

The company’s progress towards a regulatory decision in the U.S. comes as chief executive McDermott has announced that he will step down once a suitable replacement is found.

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