Endologix Inc. 04.14.16
Irvine, Calif.-based Endologix Inc. has earned the CE mark for its next-generation Nellix endovascular aneurysm sealing (EVAS) system. The first procedures with the new Nellix EVAS system were performed by Associate Professor Andrew Holden and Dr. Andrew Hill at Auckland City Hospital, Auckland, New Zealand.
“The new Nellix system includes more sizes to treat a wider range of abdominal aortic aneurysm (AAA) patients, plus gives us the ability to precisely treat patients with complex iliac anatomy,” Holden commented. “In our hospital, patients with short or aneurysmal iliac arteries represent 30 percent of the diagnosed AAAs. With the new Nellix system, we now have a solution for these challenging anatomies and look forward to treating more patients. The first procedures with the new Nellix system have been a success and post-procedure imaging confirmed the device was accurately deployed and the aneurysm was properly sealed.”
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire abdominal aortic aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. This next-generation Nellix EVAS System incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. Nellix is an investigational device in the United States.
“The new Nellix system was developed based upon physician feedback over the past two years,” said CEO of Endologix John McDermott. “It incorporates several enhancements that simplify the procedure and expand the available sizes to treat a wider range of AAA patients and anatomies. We’d like to thank our physician collaborators for their many contributions during the development process and look forward to continued EVAS innovations in the future.
“The new Nellix system will be gradually introduced in Europe and other markets over the next several months, and is the same device we plan to launch in the United States following U.S. Food and Drug Administration approval. We recently submitted our final postmarket approval modules to the FDA and remain on schedule for potential PMA approval at the end of 2016 or early 2017.”
Endologix makes minimally invasive treatments for aortic disorders.
“The new Nellix system includes more sizes to treat a wider range of abdominal aortic aneurysm (AAA) patients, plus gives us the ability to precisely treat patients with complex iliac anatomy,” Holden commented. “In our hospital, patients with short or aneurysmal iliac arteries represent 30 percent of the diagnosed AAAs. With the new Nellix system, we now have a solution for these challenging anatomies and look forward to treating more patients. The first procedures with the new Nellix system have been a success and post-procedure imaging confirmed the device was accurately deployed and the aneurysm was properly sealed.”
The Nellix EVAS System is a new generation of AAA therapy designed to seal the entire abdominal aortic aneurysm sac. It is the first and only EVAS product and was developed to reduce all types of endoleaks and improve long-term patient outcomes. This next-generation Nellix EVAS System incorporates design improvements to enhance ease of use and offers physicians more sizes to treat more patients with AAA. Nellix is an investigational device in the United States.
“The new Nellix system was developed based upon physician feedback over the past two years,” said CEO of Endologix John McDermott. “It incorporates several enhancements that simplify the procedure and expand the available sizes to treat a wider range of AAA patients and anatomies. We’d like to thank our physician collaborators for their many contributions during the development process and look forward to continued EVAS innovations in the future.
“The new Nellix system will be gradually introduced in Europe and other markets over the next several months, and is the same device we plan to launch in the United States following U.S. Food and Drug Administration approval. We recently submitted our final postmarket approval modules to the FDA and remain on schedule for potential PMA approval at the end of 2016 or early 2017.”
Endologix makes minimally invasive treatments for aortic disorders.