) announced the commercial release as well as the initial
implantations of the novel device - Crux Vena Cava Filter (VCF).
The commercial availability of this device is expected to reduce
life-risk of patients afflicted by recurrent pulmonary embolism
Pulmonary embolism is a condition characterized by blockage of
the main artery of the lung or one of its branches by a substance
which usually migrates from a different part of the body through
the bloodstream (embolism). The condition affects about 600,000
patients, resulting in 200,000 deaths annually in the United
Between Jun 2010 and Jun 2011, the Crux Biomedical Evaluation of
the Crux Inferior Vena Cava Filter System trial had been
conducted to evaluate the effectiveness and safety of the device.
The single-arm clinical trial covering 125 patients, achieved an
encouraging clinical success rate of 96%. Moreover, the problem
of filter tilt was also overcome successfully. Eventually, the
Crux VCF System received the CE Mark in Dec 2011 and 510(k)
clearance in Jul 2012.
The successful outcomes associated with the device prompted
Volcano to take over Crux Biomedical, a privately-held company
that came up with a highly differentiated inferior vena cava
(IVC) filter-the Crux VCF System-to treat pulmonary embolisms
The IVC filter market in the U.S. is estimated to be worth $300
million, and the acquisition of the innovative device can be a
major revenue driver in Volcano's core business. Currently, North
America has the highest demand, followed by Europe.
The acquisition complements Volcano's growth strategy to enter
the peripheral market and diversify beyond coronary applications.
On the other hand, Crux believes that the partnership with
Volcano will ensure widespread adoption of the state-of-the-art
Crux VCF, in the peripheral market.
Vena cava filter is a medical device which acts as a barrier for
blood clots moving to the lungs. Filters that are integrated in
the inferior vena cava (IVC) are meant to considerably reduce
repetitive PE occurrences in patients. It is an alternative
therapy for patients who are advised against conventional medical
procedures or fail to respond to available therapies.
On a larger scale, the Crux VCF is a cutting-edge therapy that
has been meticulously designed to facilitate smooth retrieval of
the filter, either through the femoral or jugular vein. Prolonged
filter retention can lead to filter fracture, filter migration,
filter embolization and IVC perforation.
Additionally, it provides filtration across the entire lumen
of the vessel. It is the only filter with a double helical design
that self-centers to help prevent filter tilt, which often
hampers the device retrieval process.
CRYOLIFE INC (CRY): Free Stock Analysis
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