Largest Prospective Study Shows IVUS-Guided Stent Placement
Improves Patient Outcomes with Current Generation of Stents
SAN DIEGO, Nov. 14, 2012 /PRNewswire/ -- Volcano Corporation
(Nasdaq: VOLC), a leading developer and manufacturer of precision
guided therapy tools designed to enhance the diagnosis and
treatment of coronary and peripheral vascular disease, today
announced that results from the largest study of its kind show that
stent procedures guided by intravascular ultrasound (IVUS) resulted
in better patient outcomes and fewer complications at 30 days and
12 months compared to procedures without IVUS, and were safe.
Enrolling 3,349 patients, the IVUS sub-study is part of the
Cardiovascular Research Foundation's (CRF) ADAPT-DES study
(Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents),
a prospective, multi-center registry of 8,583 patients with
coronary artery disease undergoing percutaneous coronary
intervention (PCI) with drug-eluting stents (DES). Results of the
ADAPT-DES IVUS sub-study were presented at the 24th Annual
Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium sponsored by CRF.
"The ADAPT-DES IVUS sub-study provides the strongest evidence to
date that use of IVUS to guide optimizing placement improves
patient outcomes," said Gregg W.
Stone, M.D., FACC, FSCAI, Professor of Medicine at
Columbia University College of Physicians and
Surgeons and Director of Cardiovascular Research and
Education at the Center for Interventional Vascular Therapy at New
York-Presbyterian Hospital/Columbia
University Medical Center. "Previously, the additive value
of IVUS as an independent predictor of stent thrombosis, myocardial
infarction (MI) and death had not been assessed in a large-scale,
prospective, multi-center registry which had sufficient power to
address these issues."
Bernhard Witzenbichler, M.D., Head of Interventional Cardiology
at Charite University of Medicine Berlin in Berlin, Germany stated, "In the study, we
found that IVUS guidance changed the therapy in more than
two-thirds of the cases, indicating that it helped the
interventionalist choose a better and more personalized treatment
path for the patient. These results add a robust new plank to the
already considerable evidence base supporting IVUS guidance as the
standard of care for stent procedures."
One-year results from the ADAPT-DES study—which is designed to
determine the frequency, timing and correlates (clinical,
angiographic and IVUS) of DES thrombosis and the relationship of
aspirin and/or clopidogrel hyporesponsiveness, and general platelet
reactivity to early and late DES thrombosis—was reported in a
Plenary Session on Thursday, Oct. 25
by Gregg W. Stone, MD, at TCT.
Key Study Results
When compared to procedures without
IVUS, IVUS-guided procedures demonstrated a 50% reduction in the
incidence of stent thrombosis (a blood clot on the surface of a
stent) and 33% reduction in MI that began as soon as 30 days post
procedure, and continued for 12 months.
No safety issues were identified in the IVUS-guided procedures
in the trial, as there was no increase in peri-procedural MI. IVUS
cases were not associated with a significant increase in the usage
of stents. The majority of stents used in this study were of the
latest generation and marketed globally.
"The ADAPT-DES IVUS results at 30 days and 12 months
meaningfully advance the field of interventional cardiology, and
also have important implications for the healthcare delivery system
as institutions seek strategies to improve the quality of care and
avoid penalties imposed by the new CMS 30-day readmission policy,"
said Scott Huennekens, President and
Chief Executive Officer, Volcano Corporation. "With the insight our
technologies such as IVUS provide, Volcano can help physicians and
healthcare institutions answer the growing demand for truly
personalized medicine that is appropriate, evidence-based and
accountable."
Volcano's Eagle Eye® Gold IVUS catheters were used in
all sub-study patients at the initiation of the sub-study and in
follow-up assessments. Analysis included assessment of lesion
morphology by using both traditional grayscale IVUS and Volcano's
proprietary VH® IVUS tissue characterization
technology.
About Volcano Corporation
Volcano Corporation is
revolutionizing the medical device industry with a broad suite of
technologies that make imaging and therapy simpler, more
informative and less invasive. Its products empower physicians
around the world with a new generation of analytical tools that
deliver more meaningful information - using sound and light as the
guiding elements. Founded in cardiovascular care and expanding into
other specialties, Volcano is changing the assumption about what is
possible in improving patient outcomes by combining imaging and
therapy together.
Forward-Looking Statements
This press release
contains forward-looking statements within the meaning of the U.S.
Private Securities Litigation Reform Act of 1995. Any statements in
this press release regarding Volcano's business that are not
historical facts may be considered "forward-looking statements."
Forward-looking statements are based on management's current
expectations and are subject to risks and uncertainties that may
cause Volcano's actual results to differ materially and adversely
from statements contained herein. Some of the potential risks and
uncertainties that could cause actual results to differ include the
effect of competitive factors and the company's reactions to those
factors; purchasing decisions with respect to the company's
products; the pace and extent of market adoption of the company's
products and technologies; uncertainty in the process of obtaining
regulatory approval or clearance for Volcano's products or devices;
the success of Volcano's growth strategies; timing and achievement
of product development milestones; outcome of ongoing or future
litigation; the impact and benefits of market development; our
ability to protect our intellectual property; dependence upon third
parties; unexpected new data, safety and technical issues; market
conditions and other risks inherent to medical and/or telecom
device development and commercialization. These and additional
risks and uncertainties are more fully described in Volcano's
filings made with the Securities and Exchange Commission, including
our most recent quarterly report on Form 10-Q, and other filings
made with the Securities and Exchange Commission. Undue reliance
should not be placed on forward-looking statements, which speak
only as of the date they are made. Volcano disclaims any 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.
SOURCE Volcano Corporation