Spectranetics Announces First Laser Lead Extraction Procedures in Japan

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Wed Aug 27, 2008 6:00am EDT

Fast Track Approval Received
COLORADO SPRINGS, Colo.--(Business Wire)--
Spectranetics Corporation (Nasdaq:SPNC) today announced the first
use in Japan of its Spectranetics Laser Sheath (SLS(R) II) technology
for removal of cardiac leads. The SLS II approval by the Ministry of
Health, Labor and Welfare is one of just three medical device
technologies chosen annually under a fast track review in Japan. This
technology has been used in the United States and Europe for over a
decade in over 45,000 successful procedures and is an important tool
to manage lead-related issues that may arise in the roughly 4 million
pacing and defibrillation leads implanted annually in patients
worldwide.

   Two procedures were recently performed at Tokyo Women's Medical
University by Dr. Morio Shoda, Chief of Clinical Cardiac
Electrophysiology and Associate Professor of Cardiology, and Dr.
Satoshi Saito, Assistant Professor of Cardiovascular Surgery, under
the proctorship of Dr. Roger Carrillo, the Director of Surgical
Electrophysiology at the University of Miami. Both cases involved
leads that were infected, and all leads were successfully removed from
the heart and encapsulating scar tissue using the SLS II Laser sheath
without complication.

   Dr. Shoda commented, "I am very pleased to begin using the SLS II
Laser Sheath to remove leads from Japanese patients for whom this form
of management is needed. Now in Japan we can safely address the needs
of many patients with implantable pacemakers and defibrillators
without subjecting them to more invasive surgical procedures."

   Dr. Roger Carrillo added, "In my years of experience with lead
extraction procedures, the laser sheath is an indispensable tool that
has helped me remove leads in a very safe, effective and efficient
manner in hundreds of patients. In this first case in Japan, the laser
sheath was successful in extracting a chronic lead where all other
techniques had previously failed."

   "Japan is an important market for Spectranetics and the recent
fast track approval for our SLS II Laser Sheath is a key first step
towards commercialization in Japan, supported by our distribution
partner, DVx Japan. We will launch this technology commercially
following reimbursement approval for the SLS II, which is currently
under review by Japan's Ministry of Health, Labor and Welfare," stated
John Schulte, Spectranetics' chief executive officer.

   As an escalating number of patients receive implanted cardiac
devices, concerns surrounding lead management options have risen.
Infection continues to be a primary cause for concern with leads,
although lead malfunction and patient lifespan are increasingly
causing physicians to consider lead removal versus lead abandonment,
the current standard-of-care practice.

   The SLS II uses "cool" ultraviolet light to safely, effectively
and efficiently ablate scar tissue that holds problematic leads in
place. A circle of fibers that emit pulses of energy travels over the
cardiac lead to dissolve scar tissue that binds the lead to the body.
Once the scar tissue is dissolved, the lead can be safely removed.
Spectranetics is also in the process of seeking approval of the Lead
Locking Device (LLD) technology in Japan, which can be used to assist
removal with the SLS II by transmitting traction on the lead from
within its hollow inner structure.

   About Spectranetics

   Founded in 1984, Spectranetics manufactures and sells the only
excimer laser approved in the United States, Europe and Japan for use
in minimally invasive cardiovascular procedures. This technology
treats complex cardiovascular conditions by photo-ablating multiple
lesion types into tiny particles that are easily absorbed into the
blood stream. The Company's disposable catheters use high-energy
"cool" ultraviolet light to vaporize arterial blockages in the legs
and heart, as well as scar tissue encapsulating pacing and
defibrillation leads. For more information visit
www.spectranetics.com.

   Safe Harbor Statement

   This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934. Such statements are based on
current assumptions that involve risks and uncertainties that could
cause actual outcomes and results to differ materially. These risks
and uncertainties may include market acceptance of excimer laser
atherectomy technology, increasing price and product competition,
increased pressure on expense levels resulting from expanded sales,
marketing, product development and clinical activities (including with
regard to the products to be acquired from Kensey Nash), uncertain
success of the Company's strategic direction, dependence on new
product development, intellectual property claims of third parties,
availability of inventory from suppliers, the receipt of FDA approval
to market new products or applications and the timeliness of any
approvals (including with regard to the products to be acquired from
Kensey Nash), market acceptance of new products or applications,
product defects, ability to manufacture sufficient volumes to fulfill
customer demand, availability of vendor-sourced components at
reasonable prices, the integration of the products to be acquired from
Kensey Nash into the Company's distribution and sales operations,
unexpected delays or costs associated with the Company's relocation
and consolidation of its headquarters and manufacturing operations,
and price volatility due to the initiation or cessation of coverage,
or changes in ratings, by securities analysts. For a further list and
description of such risks and uncertainties that could cause the
actual results, performance or achievements of the Company to be
materially different from any anticipated results, performance or
achievements, please see the Company's previously filed SEC reports.
Spectranetics disclaims any intention or obligation to update or
revise any financial projections or forward-looking statements,
whether as a result of new information, future events or otherwise.

COMPANY CONTACT:
Spectranetics Corporation
Guy Childs, Chief Financial Officer, 719-633-8333
or
INVESTOR & MEDIA CONTACTS:
Lippert/Heilshorn & Associates, Inc.
Don Markley or Bruce Voss, 310-691-7100
dmarkley@lhai.com

Copyright Business Wire 2008
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