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March 18, 2009

Olympus Medical Systems
in collaboration with Medinol announces the release
of the X-Suit NIR®,
biliary metallic stent featuring exceptional anatomic conformability to Europe ,
the U.S. and parts of Asia.

—Expanding the business of EndoTherapy devices through the metallic stent market—

X-Suit NIR® Biliary Metallic Stent

X-Suit NIR® Biliary Metallic Stent

Olympus Medical Systems Corp. (President: Haruhito Morishima) in collaboration with Medinol Ltd. (Tel Aviv, Israel, CEO: Judith Richter) announces the release of the X-Suit NIR® , biliary metallic stent*1 . Featuring exceptional anatomic conformability, this device will launch in Europe and the parts of Asia on March 27th 2009 followed by the U.S. on April 24th 2009. The product will be launched in Japan and other territories around the world after obtaining marketing approval from the regulatory authorities.

Olympus, as a leading company of gastrointestinal endoscopes, has commercialized a variety of duodenal endoscopes and therapeutic devices for the pancreatic biliary tract to support the diagnosis and treatment of pancreatic biliary diseases and to meet the needs of users. Olympus will continue to enhance its range of metallic stents and expand the business by offering comprehensive value in EndoTherapy devices.

*1  Metallic stent:A medical device made of a metallic mesh tube that is placed for dilating a stenosis within a vessel of the human body (i.e., blood vessel, bile duct, esophagus, trachea, and so on)

Main features

  1. Unique cell geometry, called NIRflexTM Cell Design, using a shape-memory alloy
  2. Superior radial support and high flexibility
  3. Outstanding insertion and stable deployment performance of stent delivery catheter

Haruhito Morishima, President, Olympus Medical Systems Corporation.

"I am pleased to announce that we will soon be launching a new metallic stent which is an essential component of endoscopic treatment for biliary duct lesions. This product is the fruit of years of groundwork in collaboration with an Israeli company, Medinol. The product offers both excellent radial force and flexibility, which are crucial requirements for the stents. We can confidently recommend this high-quality stent system to our customers."

Technique for deploying a biliary metallic stent

1.  Advance the delivery catheter over a guidewire through the working channel of the duodenoscope and into the papilla. Use fluoroscopic and endoscopic visualization to place the stent across the stenotic area.

Technique for deploying a biliary metallic stent
2. The stent is deployed by manually operating the delivery catheter, while maintaining the position of the stent under fluoroscopic imagery.
During deployment of the stent After deployment of the stent
During deployment of the stent After deployment of the stent

Main features

1.  Unique cell geometry, called NIRflexTM Cell Design, using a shape-memory alloy
The NIRflexTM Cell Design, with alternating narrow strut rings and wide strut rings, gives the stent superior radial force and high flexibility, which are key requirements for a metallic stent. In addition, thanks to the peak-to-valley cell construction ensures the stent surface remains smooth and point-free even when bent at a sharp angle, while the closed cell construction ensures that the struts are fully apposed to the bile duct wall. Moreover, there is virtually no foreshortening after the stent is released from the delivery catheter, and the stent can be placed precisely at the target position.

NIRflex(TM) Cell Design
NIRflexTM Cell Design

2. Superior radial support and high flexibility
The wide strut rings provide outstanding radial support, and the narrow strut rings function to release the force applied cross-sectionally in the longitudinal axis direction, giving the stent excellent flexibility. This enables the stent to fit any bile duct, even if highly curved, without buckling, and reduces the risk of restenosis.

3. Outstanding insertion and stable deployment performance of stent delivery catheter
The delivery catheter with its optimal tapering shape and hardness of the distal tip facilitates insertion into the papilla and passage through a stenosis in a bile duct. Also, the intermediate tube minimizes variations of the inner diameter even when the catheter is bent, allowing excellent deployment at a constant force from start to finish.

Specifications

Stent diameter Stent length Working length of delivery catheter
φ8mm 40mm 1900mm
60mm
80mm
100mm
φ10mm 40mm 1900mm
60mm
80mm
100mm

Corporate data of Medinol Ltd.

Name: Medinol Ltd. (http://www.medinol.com)
Established: 1992
CEO: Dr. Judith Richter
Address: Bldg. 7, Entrance A, 5th floor Kiryat Atidim, PO Box 58165, Tel Aviv, 61581, Israel
Number of employees: Approximately 200
Activities: Development and manufacturing of metallic stent and stenting systems for all medical applications.
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