SAN DIEGO, Nov. 13, 2013 /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 the commercial release and initial implantations of its
innovative Crux® Vena Cava
Filter (VCF) in patients at risk for recurrent pulmonary
embolism (PE). It is the only filter with a double helical design
that self-centers to help prevent filter tilt and offers the
Bi-Trieval™ option of retrieval via either the jugular or femoral
vein.
The first U.S. implantations of the Crux VCF were performed
by:
- Jeffrey D. Girardot, M.D.,
chairman of the Department of Radiology at Edward Hospital &
Health Services in Naperville,
IL
- Raghava Gollapudi, M.D.,
interventional cardiologist at Sharp Memorial Hospital in
San Diego, CA
- Donald Jacobs, M.D., chairman of
the Department of Surgery at Saint Louis
University School of Medicine in St Louis, MO
- David W. Trost, M.D., associate
professor of Clinical Radiology and director of Interventional
Radiology at the Weill Medical College of
Cornell University in New York,
NY
"The Crux VCF is an important development in the prevention of
recurrent PE. It was designed to address several limitations
associated with filters to date, including the central problem of
filter tilt, which can make device retrieval challenging, as well
as migration of the filter to other areas of the body, and
penetration through the wall of the inferior vena cava," said Dr.
Girardot. "The design also allows for retrieval of the filter
through either the femoral or jugular vein. This is a particularly
beneficial feature in today's healthcare environment, where there
is an increased clinical focus on removing filters from patients
when the risk of PE has been effectively reduced."
PE, which is caused by migration of a large blood clot arising
from the deep veins of the legs, a condition known as deep vein
thrombosis (DVT), affects approximately 600,000 patients and
results in an estimated 200,000 deaths annually in the United States.i Filters that
are implanted in the inferior vena cava (IVC), the large vein that
carries de-oxygenated blood from the lower half of the body into
the right atrium of the heart, are an important tool in
helping prevent potentially deadly PE in patients for whom
anticoagulation is contraindicated or ineffective.
"Study data regarding the Crux VCF suggests that it is very
successful in addressing the problem of filter tilt commonly
associated with other commercially available IVC filter
technologies. Filter tilt is a main reason why filter retrieval has
proven challenging, given that the hook is often embedded into the
vena cava wall," said Dr. Gollapudi.
The U.S. Food and Drug Administration (FDA) recommends that
removal of an IVC filter be considered as soon as protection for PE
is no longer necessary, and as soon as the removal of the filter is
both feasible and clinically indicated.ii
Published literature documents a retrieval rate of only 20 to 50
percent, with a mean retrieval rate of approximately 34
percent.iii Prolonged filter retention is associated
with adverse events, including filter fracture, filter migration,
filter embolization and IVC perforation.ii
"We worked for many years to develop the Crux VCF, and I am
thrilled that it is now on the market in the United States, where we believe it can
make a difference in reducing risk for recurrent PE, which is often
fatal," said Thomas Fogarty, M.D.,
an internationally renowned cardiovascular surgeon and founder of
Crux Biomedical, which developed the Crux VCF and was acquired by
Volcano in late 2012. "The Crux VCF represents the first major
design innovation for IVC filters in decades. Its unique
self-centering design addresses the risks of migration and tilt,
provides filtration across the entire lumen of the vessel, and
provides for the Bi-Trieval™ option of either femoral or jugular
retrieval."
"The Crux VCF is a cutting-edge therapy that meets an identified
clinical need to improve the rate of IVC filter retrievals," said
Neil Hattangadi, M.D., vice president and general manager of
Volcano's Peripheral Vascular Business Unit. "This milestone
represents one of many recent developments at Volcano that
demonstrates the company's commitment to expanding our peripheral
product offering and building on our heritage in diagnostics to
deliver new therapeutic solutions for the patients and physicians
we serve."
About the Crux Vena Cava Filter
The Crux Vena Cava Filter is designed as a non-conical, double
helix. This double helical, symmetrical design helps prevent filter
tilt, as the helical design self-centers automatically within the
vena cava upon deployment. It is the only IVC filter that
accommodates a bi-directional approach for both deployment and
retrieval.iii
The safety and effectiveness of the Crux VCF was evaluated in
the RETRIEVE 2, 3 and 4 pivotal clinical trials, which enrolled 125
patients at high risk for PE across 22 global sites.iv
Results demonstrated high rates of both successful filter
deployment (98 percent) and retrieval (98 percent). The mean time
for filter deployment was 5 minutes, and the mean time for filter
retrieval was 7 minutes, with the approach occurring by femoral
access in 85 percent of deployment cases and 70 percent of
retrieval cases. Results also showed high rates of safety and
effectiveness, with 0 percent embolization, migration (>2cm per
SIR guidelines) and filter fracture or filter tilting, and no
device-related adverse events requiring intervention reported.
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. Our 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 release that are not historical
facts may be considered "forward-looking statements." including
statements regarding the potential benefits of the products and
technologies described above, further development and expansion,
anticipated clinical trials and the impact of clinical and other
technical data. Forward-looking statements are based on
management's current expectations and are subject to risks and
uncertainties that may cause Volcano's results to differ materially
and adversely from the statements contained herein. Some of the
potential risks and uncertainties that could cause actual results
to differ include the pace and extent of market adoption of the
company's products and technologies; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected
regulatory actions or delays or government regulation generally;
the company's ability to obtain or maintain patent or other
proprietary intellectual property protection; competition in
general; government, industry and general public pricing pressures;
unexpected manufacturing issues; growth strategies; timing and
achievement of product development milestones; outcome of ongoing
litigation; the impact and benefits of market development; product
introductions; unexpected new data, safety and technical issues;
market conditions; and other risks inherent to medical 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
recent quarterly report on Form 10-Q. Undue reliance should not be
placed on forward-looking statements which speak only as of the
date they are made. Volcano 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.
i American Public Health Association. Deep-Vein
Thrombosis: Advancing Awareness to Protect Patient Lives. White
Paper. Public Health Leadership Conference on Deep-Vein Thrombosis,
Washington, D.C., February 26, 2003.
http://www.apha.org/NR/rdonlyres/A209F84A-7C0E-4761-9ECF-61D22E1E11F7/0/DVT_White_Paper.pdf.
Accessed November 8, 2013.
ii U.S. Food and Drug Administration. Safety Alerts
for Human Medical Products. August
2010.
iii Ni H, et al. Retrievable inferior vena cava
filters for venous thromboembolism. ISRN Radiology.
2013; Article ID 959452:1-8.
iv Smouse HB, et al. The RETRIEVE Trial: Safety and
effectiveness of the retrievable Crux Vena Cava Filter. J Vasc
Interv Radiol. 2013; 24:609–62.
SOURCE Volcano Corporation