Printer Friendly
The Free Library
19,604,530 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

ArthroCare Announces FDA Clearance for Coblation Treatment for Snoring; Significantly Expands Market Potential for Company's ENT Systems.


Business Editors/Health &Medical Writers

SUNNYVALE, Calif.--(BW HealthWire)--Feb. 9, 2000

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.
) for a new surgical procedure, called Coblation-Channeling(TM), for the treatment of snoring snoring, rough, vibratory sounds made in breathing during sleep or coma. The noisy breathing is the result of an open mouth and a relaxation of the palate; it is frequently induced by lying on one's back. .

Coblation Channeling is a new minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an  for treating upper airway up·per airway
n.
The portion of the respiratory tract that extends from the nostrils or mouth through the larynx.
 obstructive disorders with ArthroCare's ENTec(R) system, the company's patented Coblation(R)-based surgical system for ear, nose and throat surgery. Since June 1998, ArthroCare's ENTec system has been marketed in the United States and internationally for general ear, nose and throat procedures. It has been available in Europe for the treatment of snoring since June, 1999.

In the United States alone, over 40 million adults, including approximately 40 percent of men over the age of 50, suffer from snoring. A variety of medical factors can contribute to snoring, but uncomplicated snoring is generally due to vibration of the soft palate soft palate
n.
The movable fold, consisting of muscular fibers enclosed in mucous membrane, that is suspended from the rear of the hard palate and closes off the nasal cavity from the oral cavity during swallowing or sucking.
 and uvula uvula: see palate.  tissue causing intermittent airway obstruction.

Coblation-Channeling is performed on the soft palate under local anesthesia Anesthesia, Local Definition

Local or regional anesthesia involves the injection or application of an anesthetic drug to a specific area of the body, as opposed to the entire body and brain as occurs during general anesthesia.
. As with all other Coblation-based procedures, the bipolar surgical device operates at a relatively low temperature, enhancing precision and reducing the risk of thermal injury to surrounding tissue. Treatment time is relatively rapid, taking approximately 30 seconds per procedure as compared to up to nine minutes with other devices. Additional potential advantages of Coblation-Channeling compared to other more traditional techniques include less pain, faster healing, reduced postoperative care and the ability to perform procedures in the office rather than the operating room.

&uot;I am very happy with the ease of use of the ENTec surgical system in treating my patients with snoring problems,&uot; said Dr. Jeffrey Rawnsley, Assistant Professor, Division of Head and Neck Surgery, UCLA Medical Center UCLA Medical Center is a hospital located on the campus of the University of California, Los Angeles in Los Angeles, California. It is rated as one of the top three hospitals in the United States and is the top hospital on the West Coast according to US News & World Report. . &uot;It only takes a matter of seconds to deliver the energy necessary to treat snoring. In my experience to date, the procedure is quick, painless and can be performed in the office. In fact, some of my patients have come in during their lunch break and returned immediately to work. Compared to other technologies, the ENTec System, in my opinion, is the ideal tool for both the physician and patient.&uot;

&uot;In my private practice and as an ENT ENT ears, nose, and throat (otorhinolaryngology).

ENT
abbr.
ear, nose, and throat



ENT

ear, nose and throat.

ENT Ears, nose & throat; formally, otorhinolaryngology
 surgeon in hospitals, I have performed several hundred procedures using low frequency radio waves for thermal ablation in the nose and throat, as well as tonsillectomy tonsillectomy /ton·sil·lec·to·my/ (ton?si-lek´tah-me) excision of a tonsil.

ton·sil·lec·to·my
n.
Surgical removal of tonsils or a tonsil.
 procedures,&uot; said Dr. Magne Tvinnereim, an ENT surgeon at the Center for Sleep and Breathing Disorders, Bergen, Norway. &uot;In my experience, in controlled, objective overnight monitoring studies, this type of treatment gives optimal results. The ENTec surgical system offers a wide variety of tools, well suited for my purpose, regarding short operating time, patient comfort, and surgical results. My patients are very happy with the treatment and results. Coblation will definitely be a part of my surgical armament in the years to come.&uot;

ArthroCare's products allow surgeons to operate with a high level of precision and control, 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, shrink 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 simultaneously 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 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. 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, general surgery, and various cardiology applications.

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 for the year ended January 2, 1999 and Form S-3 dated September 28, 1999, and Form 10 Q for the quarter ended October 2, 1999. Such statements are indicated by words or phrases such as &uot;anticipates&uot;, &uot;estimates&uot;, &uot;projects&uot;, &uot;believes&uot;, &uot;intends&uot;, &uot;expects&uot;, 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.
COPYRIGHT 2000 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2000, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Feb 9, 2000
Words:812
Previous Article:Chase and Deloitte Consulting to Form New Company to Transform $3 Trillion B2B Procurement Market; First Venture to Deliver Complete...
Next Article:It's a Pokemon World as Nintendo Leads Popular Franchise Into 2000; New Line of Video Games, Toys and Movie Sequel Revealed at Toy Fair 2000.
Topics:



Related Articles
ArthroCare Introduces New ENTec Device to Treat Upper Airway Disorders; ReFlex Wand Used for Novel Coblation-Channeling Therapy.
Kobayashi to Market Arthrocare's ENT and Spinal Surgery Products in Japan; Companies Expand Marketing Partnership Beyond Arthroscopy.
Physicians Present Use of ArthroCare's Coblation-Channeling for Treatment of Upper Airway Disorders.
ARTHROCARE'S COBLATION SYSTEM TO BE USED FOR BRAIN SURGERY.
FDA Clears ArthroCare's Skin Resurfacing System; Key Patent for Treatment of Wrinkle Reduction Issues.
ArthroCare Revenues Grow 83 Percent in First Quarter; Earnings Per Share Reach $0.36.
ArthroCare Announces FDA Clearance for Minimally Invasive Treatment of Enlarged Turbinates; Rapid, Relatively Painless Office Procedure Now Possible.
Arthrocare Net Income Up 186 Percent in Fiscal 2000; Product Sales Driven By Strong Growth In Arthroscopy.
ArthroCare Announces Expanded FDA Clearance for Nucleoplasty Surgical Devices; Indication Includes Patients With Contained Herniated Discs.
ArthroCare Reports Second Quarter Revenue of $23.6 Million; EPS Reaches $0.14 With Aggressive Investment in Strategic Initiatives.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles