May 8, 2007
June 19, 2007 revised
Olympus Medical Systems
Simultaneous Worldwide Announcement of Easy-to-Use Single Balloon Enteroscope System to Reduce Small Bowel Examination Times
- Support for NBI Observation in Small Bowel as well as Esophagus, Stomach and Large Bowel (*1) -
Olympus Medical Systems Corp. (President: Haruhito Morishima) aims to provide comprehensive support for endoscopic diagnosis and treatment of conditions in the small bowel area, which can now be discovered thanks to the development of practical capsule endoscopes. It is already selling a capsule endoscope system in Europe and elsewhere, and on June 1 it plans a simultaneous worldwide launch(*3) for the Single Balloon Enteroscope System. Designed to support diagnosis and treatment, this system allows the operator to facilitate insertion and reduce examination times by manipulating a single balloon system. The Olympus Capsule Endoscope System will also go on sale in North America and Japan following the completion of the necessary legal procedures. A 510(k) (*2) notification has been filed in North America and a regulatory approval application is pending in Japan. By expanding its line-up of small bowel endoscopes, capsule endoscopes and EndoTherapy products, Olympus aims to contribute to the improvement of reliability and efficiency in the diagnosis and treatment of small bowel conditions.
|*1||In North America, a 510(k) notification has been filed concerning an NBI observation capability for the EVIS EXERA II Small Intestinal Videoscope Olympus SIF TYPE Q180.|
|*2||510(k): An application submitted to the FDA in preparation for the marketing of medical devices in the United States.|
|*3||The launch time in Japan has been changed to the end of June.|
The Single Balloon Enteroscope System will be on display at the 73rd Congress of the Japan Gastroenterological Endoscopy Society (Chairman: Prof. Kazumasa Miki, Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Toho University) which will be held in the International Convention Center PAMIR at the Grand Prince Hotel New Takanawa in Shinagawa, Tokyo, from May 9 to 11.
Summary of Key Features of the Single Balloon Enteroscope System (Japan)
- Reduced examination times thanks to easy set-up and simple operation
- High image resolution and improved insertability
- Support for narrow band imaging (NBI)
- Compatibility with existing Olympus systems
- Splinting tube made from silicone rubber-biocompatibility confirmed
Overview of Launch of Single Balloon Enteroscope System (Japan)
|Product Name||Launch Date|
|EVIS LUCERA Small Intestinal Videoscope, Olympus SIF Type Q260||The end of June,
|Balloon Control Unit (OBCU)|
|Single Use Splinting Tube (ST-SB1)|
The small bowel is less prone to disease than other parts of the gastrointestinal tract, such as the esophagus, stomach and large intestine. In recent years the development of capsule endoscopes, led by researchers in Europe and North America, has made the entire small bowel accessible for endoscopic observation. This new technology has given doctors the means to detect diseases in the small bowel, and there is now a growing need for medical procedures based on the use of flexible endoscopes to perform detailed diagnoses and EndoTherapy products to carry out tissue diagnoses and treatment.
Olympus has been a leading manufacturer of gastroenterological endoscopes since its development of the world's first practical gastrocamera in 1950. Through its work in this field, Olympus has helped to raise the quality of medical care by supplying safe, reliable and efficient medical diagnostic and treatment systems. Its contributions to the diagnosis and treatment of conditions in the small bowel have included the development of a flexible fiberscope in 1973, and a videoscope in 1997.
Medical practitioners need systems that are easy to operate and can reduce the time required for examinations. Olympus has responded to this need by introducing the Single Balloon Enteroscope System. For additional diagnostic support, Olympus has also developed a capsule endoscope for use in the small bowel. On sale in Europe and elsewhere since October 2005, this system is the subject of applications for 510(k) premarketing notification in North America and regulatory approval in Japan. It will be launched onto these markets on completion of these legal processes. With these products, Olympus aims to provide comprehensive support for endoscopic diagnosis and treatment.
"EnteroPro" System Brand Established for Products Used in the Small Bowel
Olympus will launch the Single Balloon Enteroscope System under the new "EnteroPro" brand, which symbolizes its commitment to comprehensive support for endoscopic diagnosis and treatment in the small intestinal region. Olympus will contribute to the efficient diagnosis and treatment of small bowel conditions through the further development of its accumulated technology in the field of flexible endoscopes, capsule endoscopes and EndoTherapy products.
Detailed Features of the Single Balloon Enteroscope System (Japan)
1. Reduced examination times thanks to easy set-up and simple operation
Pre-examination preparations are easy. Set-up consists of simply wetting the inner surface of the splinting tube, which is attached to the balloon control unit (sold separately), with water and passing the scope through it. The system is controlled by repeatedly inflating and deflating a single balloon via a remote controller. This eliminates the need for complex operations, thereby reducing the time required for examinations.
2. High image resolution and improved insertability
Despite the use of a high-resolution CCD, Olympus has kept the outer diameter of the distal end of the scope to just 9.2mm. The insertion section has been optimized for use with the ST-SB1 single use splinting tube, while the rigid distal end and angulation section have been shortened for enhanced maneuverability and insertability. There is also a 2.8mm forceps channel capable of accommodating a wide range of accessories.
Right: Distal end of existing product (EVIS Small Intestinal Videoscope Olympus SIF Type 240)
Left: Distal end of new product (EVIS LUCERA Small Intestinal Videoscope Olympus SIF Type Q260)
3. Support for narrow band imaging (NBI)
When used in combination with the EVIS LUCERA SPECTRUM videoscope system, this system supports not only conventional light observation but also narrow band imaging (NBI) for observation of detailed patterns in membranes.
4. Compatibility with existing systems
For effective utilization of existing assets, the EVIS LUCERA Small Bowel Videoscope Olympus SIF Type Q260 is compatible with the EVIS 240, EVIS LUCERA and EVIS LUCERA SPECTRUM.
5. Splinting tube made from silicone rubber - biocompatibility confirmed
To eliminate the risk of latex allergy, the ST-SB1 single use splinting tubes used as over-tubes for the SIF Type Q260 are all made from silicone rubber. This material has been confirmed to be biocompatible. To facilitate insertion deep into the small bowel, the inner surface of the tube has been treated with a hydrophilic lubricant coating to allow the insertion section of the endoscope to move freely.
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