September 24, 2008
New Studies Highlight Benefits of Coblation(R)-Assisted Procedures in Airway Fire Prevention and Endoscopic Sinus Surgery
CHICAGO, Sept. 24 /PRNewswire/ -- In studies presented this week at the American Academy of Otolaryngology-Head and Neck Surgery Annual Meeting, researchers found that Coblation(R)-assisted procedures eliminated the risk of airway fires, and Coblation(R)-Assisted Sinus Surgery (CASS) procedures lowered the risk of blood loss in nasal polypectomy/endoscopic sinus surgery (ESS).
Results of a study, sponsored by ArthroCare and entitled, "Device-Related Risk of Airway Fire in Oropharyngeal Surgery," presented today on the podium by Soham Roy, MD, a member of ArthroCare's Strategic Advisory Board for its ENT division, and Lee Smith, MD, compared the risk of airway fire for an electrosurgical device (Bovie) and a bipolar radiofrequency ablation wand (Coblator(R)) in a mechanical chicken cavity model. Their study found that the risk of airway fire appeared to be eliminated with Coblation, while electrosurgical devices, such as Bovie, present a significant risk of fire during open cavity surgery in oxygen-enriched environments. All experimental conditions were tested for four minutes, or until a positive result was achieved and were repeated in another model to ensure accuracy."Intraoperative fires are a well-described and devastating complication of oropharyngeal and airway surgery, some leading to severe injury and/or death," said Dr. Roy, lead investigator of the study from Children's ENT of Houston and Texas ENT Consultants. "We are currently conducting further investigations to determine the risk of airway fire with other surgical modalities, including laser, which is commonly used in ENT procedures."
At the American Rhinologic Society Fall Meeting, conducted in tandem with AAO-HNS, a study, entitled "Effect of Coblation Polypectomy on Estimated Blood Loss in Endoscopic Sinus Surgery (ESS): A Pilot Study," found that CASS was associated with a statistically significant lower estimated blood loss and blood loss per minute when compared to traditional microdebridement technique.
Surgical management of refractory chronic rhinosinusitis with nasal polyposis is typically successfully performed using ESS.(1.,2.) "Despite numerous advances in surgical instrumentation and optical aids, intraoperative hemorrhage remains a major hurtle in ESS with sinonasal polyposis," said Jose W. Ruiz, III, MD, investigator of the study and assistant professor at the University of Miami, Department of Otolaryngology. "Since adopting Coblation, reduced blood loss and improved surgical visualization have reduced our concern for complications, including orbital and intracranial injuries." The study concluded that Coblation represents a viable alternative to microdebridement for patients with nasal polyps undergoing ESS as it resulted in better visualization as a result of better homeostasis. The study was a retrospective analysis of 25 patients with nasal polyposis undergoing ESS and was conducted by investigators Jean Anderson Eloy, MD, Thomas J. Walker, MD, Roy R. Casiano, MD and Jose W. Ruiz, III, MD.
The Annual Meeting of the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) runs from September 21-24, 2008 at the McCormick Place Convention Center in Chicago, IL.
Sources: 1. Bhattacharyya N. Progress in surgical management of chronic rhinosinusitis and nasal polyposis. Curr Allergy Asthma Rep 7(3):216-220, 2007. 2. Bhattacharyya N. Influence of polyps on outcomes after endoscopic sinus surgery. Laryngoscope 117(10):1834-1838, 2007. ABOUT ARTHROCARE
Founded in 1993, ArthroCare Corporation (http://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(R) 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(R)-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(R) within key indications.
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The information provided in this press release includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, including statements regarding the strength or expected benefits of the Company's technology. Statements that are not historical facts are forward-looking statements. These statements are based on beliefs and assumptions by management, and on information currently available to management. Forward-looking statements speak only as of the date they are made, and ArthroCare undertakes no obligation to update any of them publicly in light of new information or future events. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Examples of these factors include, but are not limited to, the strength of the Company's technology and its continued adoption, unanticipated accounting issues or audit issues regarding the financial data for the periods being restated in the Company's previously announced restatement; the ability of the Company and its independent registered public accounting firm to confirm information or data identified in the review, being overseen by the Audit Committee of the Company's Board of Directors, of the scope and nature of the Company's internal controls (the "Review"); unanticipated issues regarding the Review that prevent or delay the Company's independent registered public auditing firm from relying upon the Review or that require additional efforts, documentation, procedures, review or investigation; the Company's ability to design or improve internal controls to address issues detected in the Review or by management in its reassessment of the Company's internal controls; the impact upon the Company's operations of the Review, legal compliance matters or internal controls, improvement and remediation; difficulties in controlling expenses, including costs of the Review, legal compliance matters or internal controls review, improvement and remediation; the Company's ability to become current in its SEC periodic reporting requirements; the outcome of pending litigation; general business, economic and political conditions; competitive developments in the medical devices market; changes in applicable legislative or regulatory requirements; the Company's ability to effectively and successfully implement its financial and strategic alternatives, as well as business strategies, and manage the risks in its business; the reactions of the marketplace to the foregoing; and other risks and uncertainties discussed more fully in the Company's SEC filings, including those discussed under Item 1A. "Risk Factors" in its Form 10-K for the fiscal year ended December 31, 2007.
CONTACT: Rebecca Macdonald of Porter Novelli Life Sciences,+1-303-862-5351, [email protected], for ArthroCare
Web site: http://www.arthrocare.com/