Advanced Neuromodulation Systems Announces FDA Approval of ANS' Second Rechargeable IPG
15 3월 2005 - 9:30PM
PR Newswire (US)
Advanced Neuromodulation Systems Announces FDA Approval of ANS'
Second Rechargeable IPG DALLAS, March 15 /PRNewswire-FirstCall/ --
Advanced Neuromodulation Systems, Inc. (ANS) (NASDAQ:ANSI)
announced today that it has received FDA approval to market and
sell its second rechargeable implantable pulse generator (IPG), the
Eon(TM) Neurostimulation System. "We received FDA approval for our
Eon system earlier than anticipated," said Chris Chavez, ANS'
President and Chief Executive Officer. "This is ANS' second
rechargeable system to be approved by the FDA within the past four
months, and I want to thank the agency for their prompt,
professional review and approval of our application. With approval
for our new Eon system now in hand, we will begin to manufacture
product to support a limited launch late in the second quarter and
a full market launch in the second half of 2005." ANS' Eon system
features an IPG roughly the same size as the company's Genesis(R)
IPG. Eon also can power up to 16 electrodes in a dual 8-electrode
lead configuration, similar to ANS' flagship Renew(R)
radio-frequency external battery system. The Eon system is
indicated as an aid in the management of chronic intractable pain
of the trunk and/or limbs, including unilateral or bilateral pain
associated with failed back surgery syndrome, intractable low back
pain and leg pain. "Compatible with all ANS percutaneous and
surgical (laminectomy) leads, the Eon system features constant
current stimulation delivery and a high-capacity rechargeable
battery. And while the FDA-approved labeling claim for this device
estimates seven years of battery life at high power settings
(compared to the competitor's five years at moderate usage), we are
considering submitting data to the FDA in the future to support an
even longer battery life claim. Additionally, Eon offers the
longest projected usage time between battery charges and the
fastest recharge rate of any rechargeable IPG on the market, for
greater patient convenience. It also features impressive
programming ranges for pulse width and frequency, similar to our
Renew system. And like other ANS systems, it offers both
MultiStim(R) and PC-Stim(R) (patient-controlled stimulation)
capabilities," Chavez said. "The pain practitioner's choice of a
neuromodulation system is driven by considerations of product
breadth and depth, superior technology, and knowledgeable and
experienced field service support. Pain practitioners want the
flexibility to apply the right product to the right indication --
one size does not fit all, nor does one system at one price
adequately address the broad and complex clinical and economic
needs of the market. "ANS has the broadest, most advanced product
offering in the industry to address the diverse needs of
interventional pain physicians and their pain patients who suffer
from chronic pain. ANS is the only company in the world that offers
a full array of spinal cord stimulation devices to meet this
demand, including two radio-frequency powered stimulators, four
conventionally powered IPGs and now three rechargeable IPGs. We
firmly believe that each kind of system has its place in the
treatment armamentarium. With our impressive list of generators and
equally impressive list of leads and programmers, ANS is uniquely
positioned to address the broad needs of the market at many
different price points," Chavez added. The CEO concluded,
"Neuromodulation promises to be a multi-billion dollar,
multi-indication modality. The interventional neuromodulation
market now exceeds one billion dollars and continues to expand.
Neuromodulation, which was the subject of a cover story in the
March 7, 2005, edition of Business Week, continues to grow in
visibility and promise. The clinical indications that
neuromodulation can address are large, underserved and
under-penetrated. Now more than ever, neuromodulation holds the
promise to improve the quality of life for millions of people who
suffer from chronic pain and other chronic diseases. We are excited
about our mission to develop ever-improving neuromodulation
technologies to address an expanding set of clinical indications."
About Advanced Neuromodulation Systems Advanced Neuromodulation
Systems designs, develops, manufactures and markets implantable
systems used to manage chronic intractable pain and other disorders
of the central nervous system. Additional information is available
at http://www.ans-medical.com/ . "Safe harbor" statement under the
Private Securities Litigation Reform Act of 1995: Statements
contained in this document that are not based on historical facts
are "forward-looking statements." Terms such as "plan," "should,"
"would," "anticipate," "believe," "intend," "estimate," "expect,"
"predict," "scheduled," "new market," "potential market
applications" and similar expressions are intended to identify
forward-looking statements. Such statements are by nature subject
to uncertainties and risks, including but not limited to market
acceptance of our new rechargeable IPGs, as well as continued
market acceptance of our conventional IPGs and radio-frequency
powered SCS systems; competition from and the launch of new
competitive products by Medtronic, Advanced Bionics/Boston
Scientific or others, as well as other market factors that could
impede growth in or reduce sales of the Company's IPG and RF
systems, which could adversely affect revenues and profitability;
patient or physician selection of less invasive or less expensive
alternatives; adverse changes in coverage or reimbursement amounts
by Medicare, Medicaid, private insurers, managed care organizations
or workers' comp programs; intellectual property protection and
potential infringement issues; the cost, uncertainty and other
risks inherent in the intellectual property litigation against
Advanced Bionics; obtaining necessary government approvals for
other new products or applications and maintaining compliance with
FDA product and manufacturing requirements; product liability;
reliance on single suppliers for certain components; completion of
research and development projects in an efficient and timely
manner; the satisfactory completion of clinical trials and/or
market tests prior to the introduction of new products; successful
integration of acquired businesses, products and technologies; the
cost, uncertainty and other risks inherent in patent and
intellectual property litigation; international trade risks;; and
other risks detailed from time to time in the Company's SEC
filings. Consequently, if such management assumptions prove to be
incorrect or such risks or uncertainties materialize, anticipated
results could differ materially from those forecast in
forward-looking statements Such forward-looking statements speak
only as of the date on which they are made, and the Company does
not undertake any obligation to update any forward-looking
statement to reflect events or circumstances after the date of this
release. DATASOURCE: Advanced Neuromodulation Systems CONTACT:
Chris Chavez, President & CEO of Advanced Neuromodulation
Systems, +1-972-309-8000; or Investor: Neil Berkman Associates,
+1-310-277-5162, or Web site: http://www.ans-medical.com/
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