| March 10, 2006 |
Announcing the commencement of marketing for Micrus’ cerebral aneurysm
embolic coil |
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Micrus Endovascular Corporation (CEO John Kilcoyne, hereafter referred
to as Micrus) has received approval from the independent administrative
agency, Pharmaceuticals and Medical Devices Agency (PMDA), for the marketing
of its cerebral aneurysm embolic coil as of 1st March, 2006. Goodman
will commence exclusive sales throughout Japan as of 1st April, 2006. |
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1.Regarding Micrus' cerebral aneurysm embolic coils |
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Micrus has developed an embolic coil device for percutaneous treatment
in the field of cerebral vasculature (intracranial aneurysms). The predominant features of this three dimensional micro-coil are: |
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high conformability within the cranial aneurysm, with gaps unlikely to
occur after placement |
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rapid detachment time at placement |
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The important features of a coil’s performance for embolic coiling are;
not causing a rupture of the aneurysm at time of placement, and, as the
placement of the first coil (caging) is markedly difficult because it must
ensure the outer shape of the aneurysm, ease of caging (high conformability
to the shape of the aneurysm).
The distinguishing characteristic of the Micrus coil is the three-dimensional
construction that ensures high conformability to the anatomical shape of
the aneurysm, resulting in extremely high evaluations regarding its coil
performance.
Micrus’ micro-coil, having previously obtained FDA approval in the United
States and CE marking for Europe, has already achieved remarkable success
by acquiring over 30% and 60% market share in the United States and Europe,
respectively.
Within Japan, there are approximately 35,000 cases involving cerebral aneurysms
per year, and it is reported that approximately 15% of those involve embolic
coiling. With the development of devices and improvements being made,
the number of cases involving embolic coiling is increasing, with further
growth expected in the future.
Having received approval for marketing the Micrus coil, Goodman will commence
exclusive sales throughout Japan from the 1st April, 2006. |
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2.Expected business performance |
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The first year sales are expected to generate in the vicinity of 2 billion
yen, with that sales figure estimated to increase to approximately 5 billion
after three years. |
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Caging and the Micrus coil |
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 Caging refers to the use of coils in an embolization procedure for a cerebral
aneurysm. It is the act of inserting the primary coil to the inside
of an aneurysm, maintaining shape for the purpose of reducing rupture.As
evident from the angiographic photo, the action resembles that of weaving
a basket, hence the term ‘caging’. The ease of the caging is an imperative
point when evaluating the functionality of the coil. |
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 As evident by the photo to the right, the three dimensional construction
anatomically conforms to the shape of the aneurysm. Due to the ease
of caging, it has been highly recommended from both the markets of Europe
and the United States |
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（Reference） |
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 An aneurysm is an abnormal swelling of the cerebral vasculature.
In Japan, it is estimated that of every 10,000 people, 1.5 to 2 people
will incur a rupture of a cranial aneurysm and further suffer a subarachnoid
hemorrhage. Subarachnoid hemorrhage can lead to hemorrhagic stroke,
cerebral functional disorder and, in the worst case scenario, death.
Therefore, it is imperative to undergo treatment to minimize the potential
for an aneurysm to rupture once an aneurysm is detected. |
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 Of those patients with cranial aneurysms, it is estimated that approximately
0.2-0.3% of patients incur a hemorrhage every year.
In the United States, a ruptured aneurysm leading to a subarachnoid hemorrhage
occurs in over 30,000 people per year. Of those, 10-15% are pronounced
dead before arriving at a hospital, and over 50% die within 30 days of
incurring a rupture. |
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The main treatment procedures for cranial aneurysms are either craniotomy
(neurosurgical clipping) or endovascular procedure (coil embolization). |
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Craniotomy (neurosurgical clipping) |
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Through a surgical opening in the skull, the vessel with an aneurysm is
confirmed and a metal clip is placed at the base of the aneurysm to prevent
blood from entering.
In craniotomy, the psychical burden on the patient is considerably large. |
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Endovascular procedure (coil embolization) |
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A catheter is inserted into the femoral artery and, passing through the
aorta, is advanced to the cerebral aneurysm. Passing through the
catheter, the embolic material (extremely thin Platinum coil) occludes
the aneurysm, thus preventing rupture by blocking blood from entering the
aneurysm. By inserting the coil into the aneurysm, thrombus forms
naturally, and therefore drastically reduces the risk of the aneurysm rupturing.
Coil embolization differs from a surgical operation in that there is no
need to perform craniotomy, so this treatment method places minimal physical
burden on the patient (being minimally invasive). |
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| Images of treatment using embolic coiling |
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| Available from Micrus Endovascular Corporation website |
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