Preliminary Results of the LIFE Study Presented at VIVA 2015
November 03 2015 - 12:45PM
Improved Patient Outcomes and Compelling Economic
Data with the Ovation® Platform and a Fast-Track EndoVascular
Aortic Repair (EVAR) Protocol
TriVascular Technologies, Inc. (NASDAQ:TRIV), manufacturer of the
Ovation Abdominal Stent Graft platform, announced today the
presentation of the midterm results of the multicenter Least
Invasive Fast-Track EVAR (LIFE) study, during the late breaking
clinical trials session at the VIVA 2015 meeting. The results were
presented by Zvonimir Krajcer, MD, FACC, Co-Director, Peripheral
Vascular Disease Service at Texas Heart Institute in Houston,
Texas, who is one of the LIFE Study co-national principal
investigators along with Venkatesh G. Ramaiah, MD, FACS, Director
of Research at the Arizona Heart Institute and Medical Director of
the Arizona Heart Hospital in Phoenix, Arizona.
The LIFE study was initiated to determine the clinical utility
and cost effectiveness of the ultra-low profile (14F OD) Ovation
Abdominal Stent Graft platform when used under least invasive
conditions. The study is a prospective, multicenter registry for
the treatment of patients with AAA using a fast-track protocol,
consisting of appropriate patient selection, bilateral percutaneous
access, avoidance of general anesthesia and intensive care unit
admission, and next-day discharge. Patients are enrolled and
treated with EVAR if the investigator determines that the patient
can meet the fast-track protocol based on medical history and
aortoiliac anatomy. Following enrollment, patients remain in the
study regardless of whether all components of the fast-track
program are completed. Patient outcomes and resource utilization
are recorded through hospital discharge and at the 30-day follow-up
visit.
The primary endpoint of the study is the proportion of subjects
that experience a major adverse event (MAE) within 30 days of the
initial procedure. No events have been adjudicated to be an MAE and
there have not been any device related serious adverse events
reported to date. Secondary endpoints include treatment success,
vascular access complications, technical success, hospital stay,
quality of life, groin pain, as well as freedom from rupture,
conversion, Type I and III endoleaks and migration. The preliminary
data from the LIFE Study demonstrate improvement in procedure time
and length of stay as compared to a nationwide benchmark of
hospitals performing EVAR. Additional economic cost variables to be
collected include costs related to anesthesia, access method, and
30-day EVAR re-intervention.
"Preliminary results of the LIFE study are encouraging and
demonstrate improved patient outcomes and compelling economic data
when utilizing the Ovation platform and a fast-track EVAR
protocol," commented Dr. Krajcer. "Dr. Ramaiah and I are excited to
partner with TriVascular on this important registry. The results of
the LIFE study will significantly contribute to the existing
literature and add momentum to the inevitable transition toward a
fast-track, next-day discharge EVAR protocol."
A total of 250 subjects will be enrolled in the LIFE study at up
to 40 sites in the United States. To date, over 170 patients
have been enrolled.
"We are focused on developing products and providing clinical
evidence to help expand EVAR access to more patients and improve
EVAR outcomes for all patients," said Christopher G. Chavez,
Chairman, CEO and President of TriVascular. "We are excited to have
reached this major clinical milestone for the LIFE Study and are
grateful to all of the study investigators who put their trust in
our technology when caring for their patients."
The four-year results of the global Ovation Pivotal Trial were
also presented at the late breaking clinical trials session at VIVA
2015 by Manish Mehta, MD, MPH. More information on these data
and the Ovation platform can be found on
http://professionals.trivascular.com/.
Last month, TriVascular announced that the first patients have
been treated successfully with the Ovation iX™ Abdominal Stent
Graft System. Building off of the clinically proven Ovation
platform, the Ovation iX System provides physicians with options
for greater procedural consistency and ease of use.
The Ovation platform has been used in the successful treatment
of over 8,000 patients worldwide. Excellent clinical results have
been reported from both the Ovation global pivotal trial and a
501-patient European Post-Market Registry. The Ovation platform is
available for sale in over 35 countries.
About TriVascular Technologies, Inc.
- TriVascular is a medical device company developing and
commercializing innovative technologies to significantly advance
minimally invasive treatment of abdominal aortic aneurysms. The
company manufactures the Ovation Abdominal Stent Graft platform,
the lowest profile FDA-approved EVAR system, which utilizes a
novel, polymer-based sealing mechanism. TriVascular is based in
Santa Rosa, California.
Forward-Looking Statements
In addition to the historical information, this
press release contains forward-looking statements with respect to
our business, the Ovation system, the Ovation iX System, our stent
graft technology, our clinical studies and our ability to expand
EVAR treatment option to a broader population of patients with AAA
disease. These forward-looking statements are based upon
information that is currently available to us or our current
expectations, speak only as of the date hereof, and are subject to
numerous risks and uncertainties, including our ability to
successfully commercialize our products and conduct our clinical
studies; continued market acceptance of our endovascular aortic
repair systems; our ability to manufacture our endovascular systems
to meet demand; the level and availability of third party payor
reimbursement for our products, our ability to effectively manage
our anticipated growth; our ability to protect our intellectual
property rights and proprietary technologies; our ability to
operate our business without infringing the intellectual property
rights and proprietary technology of third parties; our ability to
develop new or complementary technologies; the regulatory
requirements applicable to us and our competitors; competition in
our industry; additional capital and credit availability, our
ability to attract and retain qualified personnel; product
liability claims; and general economic and worldwide business
conditions. These factors, together with those that are described
in greater detail in our Annual Report on Form 10-K filed with the
SEC on March 9, 2015 and our other filings with the SEC, may cause
our actual results, performance or achievements to differ
materially and adversely from those anticipated or implied by our
forward-looking statements. We expressly disclaim any obligation,
except as required by law, or undertaking to update or revise any
such forward-looking statements.
CONTACT: Company Contact:
TriVascular Technologies, Inc.
Michael Kramer
Chief Financial Officer
707-543-8709
mkramer@trivascular.com
Media Contact:
TriVascular Technologies, Inc.
Vivek K. Jayaraman
VP, Sales & Marketing
707-543-8804
Investor Relations Contact:
Westwicke Partners
Jamar Ismail
415-513-1282
jamar.ismail@westwicke.com
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