Endologix Inc.01.31.17
Endologix Inc., developer and marketer of treatments for aortic disorders, is reporting positive 3-year clinical data from the Ovation European Post Market Registry.
The Ovation European Post Market Registry included a total of 501 patients enrolled across 30 European centers from May 2011 to December 2013. Through three years of follow-up, key highlights of the study results included:
“This study confirms the ability of the Ovation platform to successfully treat a broad array of patient anatomies with a high rate of treatment success and freedom from secondary intervention through mid-term follow-up. We are pleased to have revealed these impressive results at our scientific symposium this year,” said Professor Dierk Scheinert, M.D., study principal investigator.
"The addition of these European results continue to validate the excellent clinical results and durability of the ultra-low profile Ovation platform, further confirming the recently announced five-year Ovation IDE study results with real-world commercial data," said John McDermott, CEO of Endologix. "We would like to thank all of the investigators for their participation in this clinical study and congratulate them for their outstanding results."
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Irvine, Calif.-based company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80 percent, making it a leading cause of death in the United States.
The Ovation European Post Market Registry included a total of 501 patients enrolled across 30 European centers from May 2011 to December 2013. Through three years of follow-up, key highlights of the study results included:
- Broadest range of patient applicability on IFU of all commercially available infrarenal endovascular AAA devices
- Ninety-nine percent freedom from aneurysm-related mortality
- Ninety-nine percent freedom from migration, rupture, and conversion
- Ninety-seven percent freedom from Type I/III endoleak
- Excellent freedom from secondary intervention for occlusion (97 percent), Type I endoleak (97 percent) and Type II endoleak (95 percent)
“This study confirms the ability of the Ovation platform to successfully treat a broad array of patient anatomies with a high rate of treatment success and freedom from secondary intervention through mid-term follow-up. We are pleased to have revealed these impressive results at our scientific symposium this year,” said Professor Dierk Scheinert, M.D., study principal investigator.
"The addition of these European results continue to validate the excellent clinical results and durability of the ultra-low profile Ovation platform, further confirming the recently announced five-year Ovation IDE study results with real-world commercial data," said John McDermott, CEO of Endologix. "We would like to thank all of the investigators for their participation in this clinical study and congratulate them for their outstanding results."
Endologix Inc. develops and manufactures minimally invasive treatments for aortic disorders. The Irvine, Calif.-based company's focus is endovascular stent grafts for the treatment of abdominal aortic aneurysms (AAA). AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAA is approximately 80 percent, making it a leading cause of death in the United States.