ArthroCare Launches Spinal Surgery System in U.S.; Company Receives FDA Clearance to Market.SUNNYVALE, Calif.--(BW HealthWire)--Dec. 13, 1999-- 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 the company has received 510(k) clearance from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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. ) to market the company's Coblation(R)-based soft-tissue surgery system for spinal surgery. The company's Spinal Surgery System was introduced in Europe on September 7, 1999 and ArthroCare plans an immediate launch of the Spinal Surgery System in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. . A specialized spinal surgery sales force is in place, with a network of over 200 sales professionals at 36 distributors covering virtually the entire country. The company has already trained a majority of those sales representatives, with the remainder scheduled to complete training within the next few weeks. "We have made excellent progress toward establishing the distribution channel for our spinal surgery products and are poised for a quick product launch in the United States," said Michael A. Baker Michael Allen Baker (Captain, USN, Ret.) is the International Space Station Program Manager for International and Crew Operations, at NASA's Johnson Space Center. He is responsible for the coordination of program operations, integration and flight crew training and support , ArthroCare's president and chief executive officer. "We introduced the Spinal Surgery System in Europe at the end of the third quarter and our early experience has been extremely positive. We believe we are seeing the same benefits in spinal surgery that physicians and patients have come to expect of Coblation technology in arthroscopy Arthroscopy Definition Arthroscopy is the examination of a joint, specifically, the inside structures. The procedure is performed by inserting a specifically designed illuminated device into the joint through a small incision. , 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. , and ear, nose and throat procedures." ArthroCare's Spinal Surgery System is an extension of the company's established franchise in the orthopedic market. The system leverages the company's patented Coblation technology and the current installed base of ArthroCare's soft-tissue surgery systems. The newly introduced product set comprises the company's System 2000 radio-frequency controller unit -- the same unit currently used in arthroscopic, ear, nose and throat, and general surgery -- and a set of disposable devices optimized for spinal surgery. The disposable devices are designed for use in frequently performed spinal procedures, such as discectomies, fusions and laminectomies. ArthroCare believes spinal surgery has an estimated 1999 market size of more than $1 billion and is the most rapidly growing segment of orthopedic surgery Orthopedic Surgery Definition Orthopedic (sometimes spelled orthopaedic) surgery is surgery performed by a medical specialist, such as an orthopedist or orthopedic surgeon, trained to deal with problems that develop in the bones, joints, and ligaments , increasing in excess of 25 percent annually. Lower back pain is the most common reason for disability for people under age 50 and is the second leading cause of employee absenteeism. Back pain is the number one cause of U.S. healthcare U.S. Healthcare is a now-defunct healthcare company. The logo had an apple. The merger with Aetna In 1996, the company merged with Aetna, calling it Aetna U.S. Healthcare. The U.S. Healthcare apple logo was next to the Aetna name, and U.S. Healthcare under it. U.S. expenditures, afflicting af·flict tr.v. af·flict·ed, af·flict·ing, af·flicts To inflict grievous physical or mental suffering on. [Middle English afflighten, from afflight, an estimated 9 million Americans annually. Approximately 10 percent of all back pain patients may eventually require surgery. Chronic back pain is estimated to cost the nation more than $50 billion per year in direct and indirect medical expenses. ArthroCare's products allow surgeons to operate with increased precision and accuracy, limiting damage to surrounding tissue and thereby potentially reducing pain and speeding recovery for the patient. The company's products operate at lower temperatures than traditional electrosurgical or laser surgery tools and enable surgeons to remove or shrink soft tissue and to simultaneously seal bleeding vessels. Except for historical information, this press release includes forward-looking statements that involve risks and uncertainties, including, but not limited to, the company's fundamental position, continued success of certain product lines and strategies, the strength of the company's market position, and risks as 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 January 2, 1999 and Form S-3 dated September 28, 1999, and Form 10Q for the quarter ended October 2, 1999. Such 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 expectations. The company disclaims any obligation to update any of the forward-looking statements contained herein to reflect future events or developments. 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 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. ArthroCare's systems are used to perform many types of 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. . The company's strategy includes applying its patented Coblation technology to a broad range of other soft-tissue surgical markets, including cosmetic surgery, ear, nose and throat surgery, spinal surgery and various cardiology applications. |
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