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ArthroCare Announces Expanded FDA Clearance for Nucleoplasty Surgical Devices; Indication Includes Patients With Contained Herniated Discs.


Business Editors/Medical Writers

SUNNYVALE, Calif.--(BW HealthWire)--June 4, 2001

ArthroCare Corporation (Nasdaq:ARTC ARTC Arthrocare Corp (stock symbol)
ARTC Australian Rail Track Corporation
ARTC Air Route Traffic Control
ARTC Association de la Recherche Theatrale au Canada
ARTC Andean Root and Tuber Crops
) today announced that the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has granted the company clearance to market its Perc-D(TM) family 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(R) assisted disc decompression procedures, a unique, minimally-invasive procedure the company calls Nucleoplasty(TM). 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 coagulate /co·ag·u·late/ (-lat) to undergo coagulation.

co·ag·u·late
v.
To change from the liquid state to a solid or gel; clot.
 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "FDA clearance to market this specific procedure allows us to aggressively promote Nucleoplasty to physicians, who are already familiar with the concept of decompressing de·com·press  
v. de·com·pressed, de·com·press·ing, de·com·press·es

v.tr.
1. To relieve of pressure or compression.

2.
 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 sculpt  
v. sculpt·ed, sculpt·ing, sculpts

v.tr.
1. To sculpture (an object).

2. To shape, mold, or fashion especially with artistry or precision:
 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 Arthroscopic Surgery Definition

Arthroscopic surgery is a procedure to visualize, diagnose, and treat joint problems. The name is derived from the Greek words arthron, which means joint, and skopein, which means to look at.
, cosmetic surgery cosmetic surgery, plastic surgery for cosmetic purposes, such as the improvement of the appearance of the face by removing wrinkles or reshaping the nose. , ear, nose and throat surgery, spinal surgery, neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system.

neu·ro·sur·ger·y
n.
Surgery on any part of the nervous system.
, general surgery, and various cardiology applications. The company's website is www.arthrocare.com.

Safe Harbor Safe Harbor

1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated.

2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive.
 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 Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 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 Words and Phrases®

A multivolume set of law books published by West Group containing thousands of judicial definitions of words and phrases, arranged alphabetically, from 1658 to the present.
. Actual results may differ materially from management plans.
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jun 4, 2001
Words:647
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