| October 01, 2007 |
Announcement of the acquisition of regulatory approval for the OCT Intravascular
Imaging System and OCT ImageWire |
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As of September 28th, the OCT Intravascular Imaging System and OCT ImageWire,
developed by our US subsidiary, LightLab Imaging, received regulatory approval
for Japan from the Ministry of Health, Labor and Welfare, and sales will
commence mid-October as outlined below.
Compared to existing examination equipment, LightLab Imaging’s OCT diagnostic
imaging system can observe previously imperceptible intravascular details
at a resolution approximately 10 times higher, and this allows more accurate
intravascular lesion diagnosis.
The high resolution of the OCT diagnostic imaging system allows for (1)
the diagnosis of late in-stent thrombosis for patients with drug-eluting
stents and can assist in the decision to stop antiplatelet medication,
both crucial issues in current conferences and publications, and (2) the
detection of vulnerable plaques, which are considered to be the cause of
acute myocardial infarctions. These are just a couple of examples that
were impossible with existing diagnostic devices that will be clinically
applicable in the cardiological field with the OCT diagnostic imaging system. |
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1.Product Name |
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| Intravascular OCT Imaging System |
Approval Number 21900BZX00780000 |
| Intravascular OCT Image Wire |
Approval Number 21900BZX00779000 |
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2.Commencement of New Product Sales |
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Sales Commencement Estimate: Mid-October 2007 |
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3.New Product Features |
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See attachment |
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4.Influence of New Product on Sales |
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Worldwide sales of 10 billion yen are expected 3 years after the commencement
of marketing. However, there is no amendment to the earnings forecast of
the current term that accompanies the release of the new product. |
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(FYR) |
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| Intravascular OCT Imaging System |
Intravascular OCT Image Wire |
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Precise Diagnosis Means Precise Treatment |
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| IVUS Image |
OCT Image |
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Among existing devices, IVUS (Intravascular Ultrasound) is similar in purpose,
mechanical structure and image appearance, but when the performance of
the devices are compared, OCT image resolution is shown to be a dramatic
10 times higher than that of IVUS.
As a result of this, it has become possible to perform more detailed intravascular
lesion diagnosis. OCT can be applied for the diagnosis of late stent thrombosis
and the decision of stopping medication in drug-eluting stent patients
that have lately posed problems for the field. |
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Late Stent Thrombosis |
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Through the spread of drug-eluting stents, the peculiar characteristic
of late in-stent thrombosis (proper intravascular intimal formation is
inhibited due to the drug coating or polymer, and the condition of the
bare stent inside the vessel can cause acute myocardial infarction) of
the same type of stent has come to be viewed as a problem. Patients are
required to take antiplatelet drugs for a long period, but with the high
resolution of the OCT diagnostic imaging system, the degree of intimal
formation can be precisely diagnosed, and it is anticipated that it will
be possible to specify a period for the suspension of antiplatelet therapy.
Through such a diagnosis, extremely long and unnecessary drug therapies
can be discontinued, the patient’s physical burden can be reduced, and
medical expenses can be controlled. |
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Vulnerable Plaque |
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Due to the fragility of vulnerable plaques, they rupture for various internal
and external reasons and can cause acute myocardial infarctions and acute
coronary syndrome. Vulnerable plaques are very serious ailments for a patient.
Previously, even though there was a great deal of attention focused on
the detection of vulnerable plaques, detection was quite difficult with
current clinically applicable examination modalities. The lipid or necrotic
cores of most vulnerable plaques are covered by a thin, less than 65μ
fibrous cap, and this thin fibrous cap was difficult to detect with previous
examination modalities. It can be identified with the OCT diagnostic system. |
