Endologix Reports Positive Clinical Data from Ovation® LIFE (Least Invasive Fast-Track EVAR) Study
September 20 2016 - 12:10PM
Endologix, Inc. (Nasdaq:ELGX), developer and marketer of innovative
treatments for aortic disorders, announced today positive clinical
data from the Ovation® LIFE (Least Invasive Fast-Track EVAR) study.
Zvonimir Krajcer, MD, FACC, Co-Director, Peripheral Vascular
Disease Service at Texas Heart Institute in Houston, TX, and one of
the co-national principal investigators in the LIFE study,
presented the results in a late breaking session at
Vascular
Inter
Ventional
Advances (VIVA), which is being held September
18-22 in Las Vegas, NV.
The LIFE study, which prospectively enrolled 250
patients at 34 centers in the United States, is designed to
evaluate the Ovation® Abdominal Stent Graft platform when used in
the treatment of patients with abdominal aortic aneurysms
("AAA"). The LIFE study is the first of its kind using a
Fast-Track EVAR protocol, which includes bi-lateral percutaneous
access enabled by Ovation’s ultra-low profile (14F) design,
avoidance of general anesthesia and intensive care unit (“ICU”)
admission post procedure, and next-day discharge.
Data from the LIFE study demonstrated that
Ovation met the study primary endpoint for major adverse events at
30 days. Key highlights of the presentation, with outcomes covering
one-month follow-up, include:
- Low major adverse event (MAE) rate of 0.4%
- No ruptures, conversion, or secondary interventions
- 99% and 100% freedom from type I and type III endoleak
- Fast-Track completed in 216 (87%) patients, with positive
results compared to non-Fast-Track patients:
- Procedure time of 84 minutes vs. 110 minutes
- General anesthesia use 0% vs. 18%
- ICU stay 0% vs. 32%
- Mean hospital stay 1.2 vs. 1.9 days
A cost utility analysis compared Fast-Track EVAR
to an EVAR control group of 8,306 patients identified from a
contemporary inpatient discharge database. Completion of the
Fast-Track protocol was associated with over $21,000 in
perioperative cost savings per patient relative to standard EVAR,
largely driven by differences in hospital costs.
Additionally, the 30-day EVAR hospital readmission rate in the LIFE
study was 1.6%, compared to 8% from the American College of
Surgeons National Surgical Quality Improvement Program.
Dr. Krajcer commented, “The LIFE study provides
the first clinical evidence that a Fast-Track protocol for EVAR
offers a safe and cost-effective option for eligible AAA patients.
Patients in the Fast-Track treatment group did not require ICU
admission and benefitted from shorter procedure times and hospital
stays. This has the potential to drive significant perioperative
cost-savings compared to standard EVAR for hospitals, while also
improving clinical outcomes. The LIFE study provides compelling
evidence to support the adoption of Ovation and the implementation
of the Fast-Track protocol in EVAR centers.”
John McDermott, Chairman and Chief Executive
Officer of Endologix, said, “We are extremely pleased with the
positive results from the LIFE study. The outstanding
clinical outcomes combined with the significant cost savings
provides evidence that Ovation used in conjunction with the
Fast-Track protocol is better for patients, hospitals and
payors. We look forward to building awareness of these
results and working with clinicians and hospitals to adopt Ovation
and the Fast-Track protocol for their AAA patients.”
About Endologix, Inc.Endologix,
Inc. develops and manufactures minimally invasive treatments for
aortic disorders. The 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%, making it a leading cause of
death in the U.S. Additional information can be found on
Endologix's website at www.endologix.com.
Forward-Looking StatementsThis
communication includes statements that may be "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995, including with respect to the potential
adoption of a Fast-Track protocol by clinicians and hospitals, the
accuracy of which are necessarily subject to risks and
uncertainties, all of which are difficult or impossible to predict
accurately and many of which are beyond the control
of Endologix. Many factors may cause actual results to differ
materially from anticipated results, including unanticipated
clinical outcomes and competitive pressures. Undue reliance
should not be placed on forward-looking statements, which speak
only as of the date they are made. Endologix undertakes
no obligation to update any forward looking statements to reflect
new information, events or circumstances after the date they are
made, or to reflect the occurrence of unanticipated events. Please
refer to Endologix's Annual Report on Form 10-K for the
year ended December 31, 2015, and Endologix's subsequent
filings with the Securities and Exchange Commission, for more
detailed information regarding these risks and other factors that
may cause actual results to differ materially from those expressed
or implied.
COMPANY CONTACT:
Endologix, Inc.
John McDermott, CEO
Vaseem Mahboob, CFO
(949) 595-7200
www.endologix.com
INVESTOR CONTACTS:
The Ruth Group
Nick Laudico (646) 536-7030
Zack Kubow (646) 536-7020
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