Doctors from Texas Heart Institute (THI) at Catholic Health Initiatives (CHI) St. Luke’s Health Baylor St. Luke’s Medical Center made Texas history by implanting a new device in patients in danger of developing an aortic aneurysm rupture, which is the primary cause of death for thousands of Americans each year. Specifically, abdominal aortic aneurysms are balloon-like bulges in the main artery carrying blood from the heart to the kidneys. They are usually treated with implanted stents that bridge the aneurysm and provide structural stability. The downside of stents is that they allow endoleaks and can migrate in the artery after placement.
To address these concerns, THI chose to participate in clinical studies to prove the safety and efficacy of the Nellix Endovascular Aneurysm Sealing System, which was developed by California-based Endologix, Inc. There are 130 patients enrolled in the study, which is called EVAS FORWARD-IDE, and 30 locations in the United States, Europe, and Canada are involved. “We are excited to participate in this trial and help advance treatment options for our patients,” stated Dr. Neil Strickman, co-investigator for the trial who implanted the first device on March 11, 2014. “We also know that about 20 percent of stent patients need some sort of further treatment and we are hopeful that this device will eliminate that need.”
Nellix is unique in that it is a polymer designed to seal the aneurysm rather than bridge it. Doctors use a catheter to deliver the polymer and seal the aneurysm sac to prevent leaks and rupture. According to Dr. Zvominir Krajcer, principal investigator at THI, Nellix is unlike stents because it eliminates endoleaks and can be used to treat a wider range of vessels in the body. During preliminary evaluations, Nellix was used to treat patients that otherwise would not have been eligible for endovascular aneurysm repair. According to Endologix, physicians like the ease of use and versatility of Nellix.
Endologix currently has two products available in the United States and Europe: AFX Endovasular AAA System and IntuiTrak Powerlink System. Both are endovascular devices that treat abdominal aortic aneurysms. Nellix is accompanied by one other product in development: Ventana Fenestrated System, which is indicated for endovascular repair of juxtarenal/pararenal aneurysms.