New Studies Presented at EuroSpine are Among Several Demonstrating Pain Reduction and Improved Functionality for Minimally Invasive Procedure
AUSTIN, Texas, Oct. 2 /PRNewswire/ -- Two studies on plasma disc decompression that will be presented this week at EuroSpine in Brussels found that the procedure is effective for treating patients with contained disc herniation. PDD is a minimally invasive surgical procedure that can be performed under local anesthesia and light sedation.
A prospective, randomized, controlled study of 85 patients comparing PDD to conservative care for the treatment of contained cervical disc herniation presented by Alessandro Cesaroni, MD, vice chief in neurosurgery, Policlinico Casilino Hospital, Rome, Italy, found that PDD patients enjoyed earlier resolution of symptoms and functional improvement, and had significantly greater pain relief at 12 months. Dr. Cesaroni's data will also be presented from the podium at the World Federation of Neurological Societies Annual Meeting in November. Last month, his study was presented at the Annual Meetings of the European Association of Neurological Societies and the Congress of Neurological Surgeons.
"In our study, we determined PDD to be an effective alternative for patients who experience pain and symptoms associated with cervical disc herniation that do not resolve spontaneously over time. PDD patients experienced significantly greater reduction in pain than patients under conservative care at both six- and twelve-month follow-up visits," said Dr. Cesaroni.
In a separate and ongoing prospective, randomized controlled study, investigators at 12 sites have enrolled 89 patients with radicular pain associated with contained disc herniation and treated with PDD. Preliminary results from 36 patients will be presented as a poster at EuroSpine. The study's initial findings, comparing PDD to selective nerve root injections (SNRI) for the treatment of contained disc herniation, revealed PDD patients showed greater reduction in both leg and back pain than SNRI patients at six months following treatment. The results were also presented at the Congress of Neurological Surgeons Annual Meeting last month and will be presented in October at the North American Spine Society Annual Meeting.
Also presented recently from the podium at the European Association of Neurological Societies in September was a retrospective review of more than 1,000 patients treated with PDD that found that 79 percent of patients reported "excellent" or "good" alleviation of pain and symptoms, with a procedure-related complication rate of less than 0.6 percent through 12 months. The study was conducted by Dr. Alberto Alexandre, MD, director of the European Neurosurgical Institute, Treviso, Italy. The study will also be presented from the podium at the World Federation of Neurological Societies Annual Meeting in November.
PDD is indicated for the treatment of patients with symptoms associated with a contained disc herniation. The procedure utilizes Coblation(R), a patented technology that uses electrical energy combined with a conductive medium, such as saline solution, to form a plasma that gently and precisely dissolves soft tissue, such as disc nucleus, at relatively low temperatures, minimizing damage to adjacent, healthy tissue. The result is that when a portion of the disc nucleus is removed, the herniated disc is decompressed. Approximately 100,000 PDD procedures have been performed to date. The Federal Food and Drug Administration cleared Coblation for use in PDD procedures in 2001.
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.
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 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 June 30, 2007 and Form 10-K for the year ended Dec. 31, 2006. 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: Kellie Reagan
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|SOURCE ArthroCare Corporation|
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