GOODMAN Co.,Ltd.

November 08, 2007

Announcement of successful in-vivo clinical cases of next-generation OCT diagnostic device under development by LightLab Imaging

During the PCI live at the Transcatheter Cardiovascular Therapeutics conference, held from October 20th in Washington D.C., in-vivo clinical use of the next-generation OCT diagnostic device (temporary name “Scanning Laser OCT: SL-OCT”) being developed by Goodman’s wholly-owned subsidiary, LightLab Imaging (Massachusetts, USA) was transmitted live to the crowd of over 1,000 participants in the main hall with a phenomenal reception.

The live case was performed by Prof. Dr. Eberhard Grube, of the　Helios Heart Center in Siegburg, Germany. He commented “The images from this device are so detailed and …this is such a huge step up in ease of use. I think we are all very fascinated. It makes a beautiful image, and now we are looking at things in a much different way.”

“This is the most excitement I’ve seen at this meeting in two or three years,” commented Dr. Gary Mintz, Chief Medical Officer of the Cardiovascular Research Foundation (CRF, the sponsor of TCT).

Moderator Gregg W. Stone, M.D., Professor of Medicine at Columbia University and Chairman of CRF, commented “the audience was amazed at these images.”, which showed a recently implanted stent and the tissues covering the stent struts with a resolution of approximately 15-20 microns, more than 10 times the resolution of today’s more commonly used intra-coronary imaging technology, known as IVUS, or intra-vascular ultrasound. Dr. Stone noted, “The difference is resolution between OCT and IVUS is extraordinary. This should significantly improve our ability to make accurate decisions for patients.”

“SL-OCT” is an intravascular imaging system that uses the principle of frequency domain optical coherence tomography (FD-OCT). LightLab Imaging is the first in the world to achieve successful clinical application with a production model system that utilizes FD-OCT. LightLab Imaging’s current system “M2 OCT” utilizes the principle of time domain optical coherence tomography (TD-OCT).
In comparing “SL-OCT” to the current system, an even faster, higher resolution, higher image quality imaging system has been realized.

Main Features:

1)An increase in speed results in a reduction of required time for imaging

As the components of red blood cells cause the diffuse reflection of near infra-red light, there is a necessity to remove blood from the intravascular observation site when performing OCT imaging. The current system uses methods such as proximal blood flow occlusion with an occlusion balloon catheter. However, since the necessary time for imaging has been reduced to approximately one tenth of the previous requirement with SL-OCT, rapid imaging is possible without blood flow occlusion. Due to this improvement, not only does actual clinical use become even simpler, but the physical burden on the patient is also reduced.

2)High resolution, high image quality

SL-OCT possesses a higher sensitivity than the current system, and its resolution is approximately 3 times higher. This allows for even more detailed intravascular observation, and leads the way to 3D intravascular imaging.

3)Examples of expected applications for clinical diagnosis:

①	Due to the resolution increase over the current system, further improved diagnosis of vulnerable plaques, one of the causes of heart attacks
②	The identification of the presence of thrombus following coronary stent treatment, and image diagnosis that helps to decide endpoints for the treatment of incomplete stent apposition, thought to be a cause of late in-stent thrombosis.
③	Auxiliary diagnosis for determining the period to discontinue antiplatelet therapy in drug-eluting stent patients, an important current issue.


SL-OCT system	M2-OCT system

3D OCT Reconstructions: M4 in vivo