Healthcare Industry News: allergic rhinitis
News Release - March 18, 2008
ArthroCare Announces Reflex Ultra(R) PTR Plasma Wand Designed for Precise Turbinate Reduction in Pediatric PatientsProspective Study Measures Effectiveness of Coblation(R) Technology in Treating Nasal Obstruction in Pediatric Population's Smaller Anatomy
AUSTIN, Texas--(HSMN NewsFeed)--ArthroCare® Corp. (NASDAQ:ARTC ), a leader in developing state-of-the-art, minimally invasive surgical products, announced today the launch of the ReFlex Ultra® PTR Plasma Wand. The wand is designed for use in volumetric turbinate reduction procedures to treat nasal airway obstructive disorders – such as turbinate hypertrophy in allergic rhinitis for pediatric patients.
The Reflex Ultra PTR Plasma Wand utilizes Coblation® technology to remove and/or shrink turbinate tissue but is designed with a sharpened lead electrode with a shorter, smaller diameter shaft. The wand allows for easy entry into turbinate tissue with increased precision and accuracy while reducing visual obstructions typical when treating the smaller anatomy of pediatric patients.
By ArthroCare’s estimates, there are approximately 182,000 children in the United States who suffer from nasal obstruction and are potential candidates for turbinate reduction. Turbinates are located on the inside of the nasal cavity and if enlarged can obstruct breathing.
Coblation is an advanced technology that combines gentle radiofrequency energy with a saline solution to quickly and safely remove soft tissue. Coblation works by breaking the molecular bonds, thereby leaving surrounding healthy tissue intact unlike conventional electrosurgery and laser surgery, which rely on high levels of heat. In turbinate reduction procedures, this lower-temperature technique allows for removal of target tissue without damaging surrounding tissue or altering the critically important nasal mucosal lining – preserving normal nasal function and leaving facial growth unaffected.
“My pediatric patients experience a very rapid recovery with the use of Coblation in turbinate reduction. The pain is minimal, and swelling resolves quickly so that these pediatric patients usually return to school the next day,” said Seth Pransky, M.D. director of Pediatric Otolaryngology at Rady Children’s Hospital of San Diego. “The smaller wand offers enhanced precision while working with the smaller intranasal anatomy of children.”
A prospective multi-center study investigating the effectiveness of Coblation turbinate reduction to treat nasal obstruction symptoms in a pediatric population has recently been initiated. The study is designed to determine the long-term impact of Coblation on turbinate reduction for the management of nasal obstructive symptoms. “The ability to customize treatment is particularly important for the pediatric patient whose smaller nasal anatomy is more significantly impacted by turbinate hypertrophy,” added Dr. Pransky, who is also lead investigator on the study. The study’s primary endpoint will be assessed by change in nasal obstruction symptoms at 6 weeks after the surgical procedure. A validated health-related quality of life questionnaire is administered to patients before and after the surgical procedure to compare nasal obstruction symptoms and measure the procedure’s effectiveness.
Founded in 1993, ArthroCare Corporation (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 2008, 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-Q for the quarter ended September 30, 2007 and Form 10-K for the year ended Dec. 31, 2007. 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.
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