April 18, 2016

Launch of Single Use Aspiration Needle
Designed to Provide for Shorter Procedure Times in Use with
Endoscopic ultrasound-guided Fine Needle Aspiration
Olympus Corporation (President: Hiroyuki Sasa) today announced the launch thisspring by its Medical Business of the Single Use Aspiration Needle EZ Shot 3 Plus, a new
product in its gastrointestinal portfolio. After the initial launch in Europe and parts of theAsia-Pacific region, it will become available in a global rollout to other markets as therelevant requirements are satisfied (product registration, or market clearance). This
instrument was designed to be used with an ultrasound endoscope for ultrasonicallyguided fine needle aspiration (EUS-FNA) of submucosal and extramural lesions within thegastrointestinal tract (i.e. pancreatic masses, mediastinal masses, perirectal masses andlymph nodes).
The aspiration needle sheath*1 that is inserted into the ultrasonic endoscope has been
made flexible to provide unparalleled access to the pancreatic head, which is difficult toreach. The needle is made from holding memory metal intended to hold its shape.
Together with a sharpened tip, EZ Shot 3 Plus helps physicians avoid problems
associated with difficulty in targeting due to a bent needle, and, thus, potentiallyshortening procedure times.
*1: The needle is encased in a coil-shaped sheath (see photograph on next page).

Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA)
EUS-FNA, an examination technique that uses an ultrasound endoscope, enables physicians totake tissue or cell biopsies of lesions in locations such as the pancreas that cannot be accessed
directly by the endoscope. One such example is by performing a needle biopsy through the wallof the gastrointestinal tract with the ultrasound scope being inserted orally and the ultrasoundutilized for sub-mucosal imaging. The collected tissue can then be sent for pathology testing tocheck whether it is benign or malignant by examination under a microscope.
●Launch Overview
Product Name
Single Use Aspiration Needle NA-U200H
EZ Shot 3 Plus

Single Use Aspiration Needle EZ Shot 3 Plus

-1-●Main Features
1. Flexibility that provides uncompromised access to difficult-to-approach locations suchas in the pancreatic head, helps physicians insert the needle into the endoscope, evenwhen the end of the scope is tightly curved. This helps shorten procedure times byreducing scope adjustments to accommodate the needle.
2. The needle tube is made of nitinol, a material that is flexible and has shape memory. The
sharply pointed Menghini tip helps physicians to puncture the tissue and lesion at thetarget location.
●Development Background
Endoscopic ultrasound-fine needle aspiration (EUS-FNA)
was first used in the early 1990s, primarily in Europe andAmerica. Its use has since become increasingly widespreadas an exploratory technique for taking tissue or cell samples
from lesions for definitive pathology diagnosis.
Uses for EUS-FNA include cases that require
the needle to be inserted into difficult-to-accesslocations, such as in the pancreatic head thatcan only be reached with a high degree ofcurvature in the tip of the endoscope, as shownin the figure above. In such cases, the sheath
inserted into the endoscope must be able to pass smoothly through the curved scope with minimalforce. Furthermore, if the subsequent steps, which include adjusting the angle of the needle andits withdrawal and insertion to collect the tissue sample, can be performed without difficulty, thenprocedure times may be reduced. In order to achieve an accurate diagnosis it is helpful for theneedle to be easy to insert into the target location. The Single Use Aspiration Needle EZ Shot 3
Plus was developed with the aim of satisfying these requirements.
●Details of Main Features
1. Flexibility that provides uncompromised access to difficult-to-approach locations suchas in the pancreatic head, helps physicians insert the needle into the endoscope, evenwhen the end of the scope is tightly curved. This helps shorten procedure times byreducing scope adjustments to accommodate the needle.
The needle is inserted into the endoscope shrouded in a coil-shaped sheath that provides
flexibility and smooth force transmission from the handle. The sheath facilitates access todifficult-to-approach locations such as in the pancreatic head by making the Single Use
Aspiration Needle EZ Shot 3 Plus easy for physicians to insert and deploy the needle, even ifthe tip of the ultrasound endoscope is tightly curved. Furthermore, the sheath’s multi-layer
construction minimizes friction with the needle, which allows the needle to travel freely andsmoothly.

-2-2. The needle tube is made of nitinol, a material that is flexible and has shape memory. The
sharply pointed Menghini tip helps physicians to location.
During an EUS-FNA procedure, the needle may be inserted into suspected lesions at a numberof different locations or depths. The needle’s shape memory helps prevent it from bending after
multiple passes. A bent needle would hinder accurate puncture at the desired location andpossibly reduce visibility on ultrasound. Furthermore, the sharply pointed Menghini tip is
intended to help physicians to puncture tissue smoothly, even from an oblique angle. Needles
are available both with and without holes along the side of the tip to satisfy physician
preference.

Needle tube with a side hole
Ultrasound image – a needle tip
can be seen in the middle●Main Specifications
Model

NA-U200H-8019

Needle Tube ShapeMaximuminsertion

NA-U200H-8022

NA-U200H-8019Swithout a side holeø 2.6

NA-U200H-8022S

with a side hole

ø 2.2

ø 2.6

ø 2.2

1922

portion diameter (mm)1400*2Working length (mm)Needle diameter (G)1922*3Maximum needle length80(mm)*2 Working length indicates the same length as when it is packed.
*3 Maximum needle length indicates an approximate length of the needle tube extended from the distal end of theneedle sheath.

The company names and product names specified in this release are the trademarks or registeredtrademarks of each company.

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