AUSTIN, Texas--(BUSINESS WIRE)--May 15, 2007--ArthroCare
(Nasdaq:ARTC), a multi-business medical device company that develops
minimally invasive surgical products, today announced it has received
clearance from the U.S. Food and Drug Administration (FDA) for its
Cavity SpineWand(R) to reduce malignant lesions within the vertebrae.
The Cavity SpineWand is used in a minimally invasive, surgical
procedure to actually remove malignant tissue within vertebrae,
creating a small cavity. Medical grade cement can then be injected
into the cavity, stabilizing the fracture. This procedure does not
eliminate other therapeutic options for the patient such as radiation
or chemotherapy.
The American Cancer Society estimates 30 to 70 percent of the more
than half a million people who die annually of cancer have skeletal
metastases and 10 percent of the 700,000 vertebral compression
fractures (VCF) that occur each year are believed to be caused by
metastatic spine tumors. Skeletal metastases, commonly referred to as
spine tumors, are caused when breast, prostate or other primary
cancers spread by the bloodstream to the spine, causing vertebrae to
weaken and collapse. VCFs can create debilitating back pain, impaired
mobility and in some cases, paralysis. In addition to decreasing
quality of life, the pain caused by VCFs may make it difficult for
many patients to receive their chemo or radiation therapies prescribed
by their oncologists.
"Creating a cavity in the tumor results in better outcomes for the
patient. Subsequent to reducing the tumor, cement augmentation can be
used with more precise cement delivery," said Dawid Schellingerhout,
M.D., assistant professor, diagnostic radiology at M.D. Anderson
Cancer Center. "Patients who have had vertebroplasty following removal
of the tumor material with the Cavity SpineWand typically report
significant pain relief - sometimes even complete reduction in pain.
In addition to the overall improvement of quality of life, the pain
reduction and improved mobility patients experience can be
instrumental in helping them comply better with chemotherapy or
targeted radiotherapy treatment."
The Cavity SpineWand utilizes Coblation(R), a patented technology
utilizing bipolar radiofrequency to gently and precisely remove soft
tissue at low temperatures, generally 40 to 70 degrees Celsius. In
this spine procedure, an interventional neuroradiologist or
neurosurgeon in consultation with a radiation oncologist, creates a
small incision and inserts a cannula to access the affected area
within spine. The Cavity SpineWand is inserted through the cannula
under radiographic guidance and is activated once it reaches the
tumor. A small, highly localized plasma cloud removes tumor material
while minimizing damage to surrounding healthy tissue.
"This is a significant step in our mission of developing
innovative therapies to improve the quality of lives of the thousands
of people living with cancer," said Jim Pacek, Vice President of
ArthroCare Interventional Therapies, a newly created division focused
on oncology. "This FDA clearance represents the first time a company
has been allowed to market a device targeted specifically to remove
malignant tissues in the vertebrae. Often, these tumors cause painful
vertebral compression fractures. We believe the Cavity SpineWand will
be a valuable tool for physicians in their effort to provide improved
outcomes for this patient population."
About ArthroCare
Founded in 1993, ArthroCare Corp. (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 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-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
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-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: FischerHealth for ArthroCare Corp.
Jeff Speer, 310-577-7870, ext. 156
jspeer@fischerhealth.com
SOURCE: ArthroCare Corporation
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