Indication Includes Patients With Contained Herniated Discs
SUNNYVALE, CA —(BW HealthWire)— June 4, 2001—
ArthroCare Corporation (Nasdaq: ARTC) today announced that the U.S. Food
and Drug Administration (FDA) has granted the company clearance to market
its Perc-Däfamily of disposable surgical devices specifically for disc
decompression to treat symptomatic patients with contained herniated discs.
Previously, the Perc-D devices had been marketed under an FDA clearance
for general spinal surgery procedures.
The FDA clearance is for Coblation® assisted disc decompression
procedures, a unique, minimally-invasive procedure the company calls Nucleoplastyâ.
The Nucleoplasty procedure is performed with the company's Perc-D family
of surgical devices, ArthroCare's patented Coblation Channeling(TM) products
for the spine. As the Perc-D device is percutaneously channeled into the
disc, tissue is ablated through Coblation technology's low-temperature
molecular dissociation process. Thermal energy is applied while withdrawing
the device to coagulate the area around the channel. Combined, these two
therapies result in disc decompression and provide treatment of symptoms
associated with contained herniated discs.
"I have been using ArthroCare's Perc-D surgical device in
my practice to treat patients with contained herniated discs,'' said Yung
Chen M.D., assistant professor of functional restoration who directs the
Stanford Interventional Spine Center. "I am extremely pleased with the
resolution of symptoms with a minimal post-operative regime that my patients
experience with the Nucleoplasty procedure. Nucleoplasty is a very promising
procedure for patients with contained herniated discs.''
"The Nucleaoplasty procedure offers physicians and their
patients a minimally-invasive, out-patient option to treat symptoms of
contained herniated discs,'' said Mike Baker, ArthroCare's president and
CEO. "FDA clearance to market this specific procedure allows us to aggressively
promote Nucleoplasty to physicians, who are already familiar with the
concept of decompressing herniated discs to treat symptomatic patients.''
ArthroCare said that over 1000 Nucleoplasty procedures have
been performed to date. The company is conducting Nucleoplasty training
sessions throughout the world and has trained more than 300 physicians
to date.
ABOUT ARTHROCARE
ArthroCare's products allow surgeons to operate with a high
level of precision and control, limiting damage to surrounding tissue.
The company's products operate at lower temperatures than traditional
electrosurgical or laser surgery tools and enable surgeons to remove,
thermally modify, or sculpt soft tissue and to seal bleeding vessels.
ArthroCare is a medical device company that develops, manufactures
and markets products based on its patented Coblation technology. ArthroCare's
soft-tissue surgery systems consist of a controller unit and an assortment
of single-use disposable devices that are specialized for specific types
of surgery. The company believes its Coblation technology can replace
the multiple surgical tools traditionally used in soft-tissue surgery
with one multi-purpose surgical system. Coblation technology is applicable
across many soft-tissue surgical markets. The company's strategy includes
applying its patented Coblation technology to a broad range of soft-tissue
surgical markets, including arthroscopic surgery, cosmetic surgery, ear,
nose and throat surgery, spinal surgery, neurosurgery, general surgery,
and various cardiology applications. The company's website is www.arthrocare.com.
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 belief in the success of novel surgical procedures, the
company's belief that certain surgical products and procedures will enhance
achievement of the company's long term potential, and other statements
that involve risks and uncertainties. These risks and uncertainties include,
but are not limited to the uncertainty of success of the companies non-arthroscopic
products, competitive risk, uncertainty over reimbursement, and the uncertainty
of protecting the company's patent position. 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 December 30, 2000, and the 10Q for the quarter ended March
31, 2001. 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 plans.
Investor Information
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