HOLLYWOOD, Fla., May 22 /PRNewswire-FirstCall/ -- Two new studies show Coblation(R) devices were effective for safely treating symptomatic chondral defects in the knee. The two studies were presented at the Arthroscopic Association of North America (AANA) annual meeting held May 18 to 21 at the Westin Diplomat Resort & Spa, Hollywood, Florida.
Coblation is a patented technology that combines bipolar radiofrequency energy with a saline solution to gently and precisely remove soft tissue at low temperatures, typically 40 to 70 degrees Celsius.
The first study, presented by Ferdinando Battistella, MD, orthopaedic surgeon at Legano Hospital (Milan, Italy) is the first clinical study to evaluate in vivo histologic findings after the use of bipolar radiofrequency-based methods in articular cartilage of the knee. Results of the study indicate this approach can be used to safely treat grades II and III lesions in the knee.
“The cells in the tissue surrounding the treated area were healthy months after the procedure, which may decrease the chance of long term degeneration,” said Battistella, lead author of the study titled: In Vivo Histology Findings Through One Year After Clinical Use of Bipolar Radiofrequency-Based Chondroplasty. “These findings are significant for orthopaedic surgeons as I have also found Coblation is easy to use and produces a smoother surface than a mechanical shaver during the debridement of articular cartilage.”
The study, conducted in Italy, included four patients awaiting total knee replacement who were treated with arthroscopic chondroplasty using Coblation. Second-look arthroscopy of treated defects in patients at six, nine and 12 months following the procedure appeared viable and stable, with no evidence of deterioration.
A second study, Osteonecrosis Following Arthroscopic Chondroplasty -- a Retrospective Evaluation of 521 Patients Who Underwent Arthroscopic Knee Surgery -- indicated no relationship between the onset of osteonecrosis and the type of surgical device used for treating symptomatic chondral defects in the knee. The study was presented by Dain Allred, MD, orthopaedic surgeon at the University of Rochester School of Medicine.
Of the 521 patients receiving arthroscopic knee surgery and treatment of chondral defects using Coblation alone, a mechanical shaver alone, or both Coblation and a mechanical shaver, there were no cases of osteonecrosis among the 52 people treated with Coblation alone. The rate of osteonecrosis following chondroplasty with a mechanical shaver was 0.98 percent (2 out of 205 people), and among those who were treated using both methods, the rate of osteonecrosis was 1.2 percent (3 out of 259 people).
For more information about bipolar radio frequency-based Coblation devices, please contact ArthroCare at 1-800-348-8929, or visit http://www.arthrocare.com.
ABOUT ARTHROCARE
Founded in 1993, ArthroCare Corp. (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 2006 and 2007, 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 Sept. 30, 2005 and Form 10-K for the year ended Dec. 31, 2005. 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.
CONTACT: Jeff Speer FischerHealth (310) 577-7870, ext. 156 jspeer@fischerhealth.com
ArthroCare Corp.
CONTACT: Jeff Speer of FischerHealth, +1-310-577-7870, ext. 156,jspeer@fischerhealth.com, for ArthroCare Corp.
Web site: http://www.arthrocare.com/
