New Studies Presented at EuroSpine are Among Several Demonstrating Pain
Reduction and Improved Functionality for Minimally Invasive Procedure
AUSTIN, Texas, Oct. 2 /PRNewswire-FirstCall/ -- Two studies on plasma
disc decompression that will be presented this week at EuroSpine in
Brussels found that the procedure is effective for treating patients with
contained disc herniation. PDD is a minimally invasive surgical procedure
that can be performed under local anesthesia and light sedation.
A prospective, randomized, controlled study of 85 patients comparing
PDD to conservative care for the treatment of contained cervical disc
herniation presented by Alessandro Cesaroni, MD, vice chief in
neurosurgery, Policlinico Casilino Hospital, Rome, Italy, found that PDD
patients enjoyed earlier resolution of symptoms and functional improvement,
and had significantly greater pain relief at 12 months. Dr. Cesaroni's data
will also be presented from the podium at the World Federation of
Neurological Societies Annual Meeting in November. Last month, his study
was presented at the Annual Meetings of the European Association of
Neurological Societies and the Congress of Neurological Surgeons.
"In our study, we determined PDD to be an effective alternative for
patients who experience pain and symptoms associated with cervical disc
herniation that do not resolve spontaneously over time. PDD patients
experienced significantly greater reduction in pain than patients under
conservative care at both six- and twelve-month follow-up visits," said Dr.
Cesaroni.
In a separate and ongoing prospective, randomized controlled study,
investigators at 12 sites have enrolled 89 patients with radicular pain
associated with contained disc herniation and treated with PDD. Preliminary
results from 36 patients will be presented as a poster at EuroSpine. The
study's initial findings, comparing PDD to selective nerve root injections
(SNRI) for the treatment of contained disc herniation, revealed PDD
patients showed greater reduction in both leg and back pain than SNRI
patients at six months following treatment. The results were also presented
at the Congress of Neurological Surgeons Annual Meeting last month and will
be presented in October at the North American Spine Society Annual Meeting.
Also presented recently from the podium at the European Association of
Neurological Societies in September was a retrospective review of more than
1,000 patients treated with PDD that found that 79 percent of patients
reported "excellent" or "good" alleviation of pain and symptoms, with a
procedure-related complication rate of less than 0.6 percent through 12
months. The study was conducted by Dr. Alberto Alexandre, MD, director of
the European Neurosurgical Institute, Treviso, Italy. The study will also
be presented from the podium at the World Federation of Neurological
Societies Annual Meeting in November.
PDD is indicated for the treatment of patients with symptoms associated
with a contained disc herniation. The procedure utilizes Coblation(R), a
patented technology that uses electrical energy combined with a conductive
medium, such as saline solution, to form a plasma that gently and precisely
dissolves soft tissue, such as disc nucleus, at relatively low
temperatures, minimizing damage to adjacent, healthy tissue. The result is
that when a portion of the disc nucleus is removed, the herniated disc is
decompressed. Approximately 100,000 PDD procedures have been performed to
date. The Federal Food and Drug Administration cleared Coblation for use in
PDD procedures in 2001.
ABOUT ARTHROCARE
Founded in 1993, ArthroCare Corporation (Nasdaq: ARTC)
(http://www.arthrocare.com) is a highly innovative, multi-business medical
device company that develops, manufactures and markets minimally invasive
surgical products. With these products, ArthroCare targets a multi-billion
dollar market opportunity across several medical specialties, significantly
improving existing surgical procedures and enabling new, minimally invasive
procedures. Many of ArthroCare's products are based on its patented
Coblation(R) technology, which uses low-temperature radiofrequency energy
to gently and precisely dissolve rather than burn soft tissue -- minimizing
damage to healthy tissue. Used in more than four million surgeries
worldwide, Coblation(R)-based devices have been developed and marketed for
sports medicine; spine/neurologic; ear, nose and throat (ENT); cosmetic;
urologic and gynecologic procedures. ArthroCare also has added a number of
novel technologies to its portfolio, including Opus Medical sports
medicine, Parallax spine and Applied Therapeutics ENT products, to
complement Coblation(R) within key indications.
SAFE HARBOR STATEMENTS
Except for historical information, this press release includes
forward-looking statements. These statements include, but are not limited
to, the company's stated business outlook for fiscal 2007, continued
strength of the company's fundamental position, the strength of the
company's technology, the company's belief that strategic moves will
enhance achievement of the company's long term potential, the potential and
expected rate of growth of new businesses, continued success of product
diversification efforts, and other statements that involve risks and
uncertainties. These risks and uncertainties include, but are not limited
to the uncertainty of success of the company's non-arthroscopic products,
competitive risk, uncertainty of the success of strategic business
alliances, uncertainty over reimbursement, need for governmental clearances
or approvals before selling products, the uncertainty of protecting the
company's patent position, and any changes in financial results from
completion of year-end audit activities. These and other risks and
uncertainties are detailed from time to time in the company's Securities
and Exchange Commission filings, including ArthroCare's Form 10-Q for the
quarter ended June 30, 2007 and Form 10-K for the year ended Dec. 31, 2006.
Forward-looking statements are indicated by words or phrases such as
"anticipates," "estimates," "projects," "believes," "intends," "expects,"
and similar words and phrases. Actual results may differ materially from
management expectations.
CONTACT: Kellie Reagan
FischerHealth
(310) 577-7870, ext. 126
kreagan@fischerhealth.com
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