Healthcare Industry News: vertebral compression fractures
News Release - May 15, 2007
ArthroCare Receives FDA Clearance to Treat Malignant Lesions in the SpineAUSTIN, Texas--(HSMN NewsFeed)--ArthroCare (Nasdaq:ARTC ), a multi-business medical device company that develops minimally invasive surgical products, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its Cavity SpineWandŽ to reduce malignant lesions within the vertebrae. The Cavity SpineWand is used in a minimally invasive, surgical procedure to actually remove malignant tissue within vertebrae, creating a small cavity. Medical grade cement can then be injected into the cavity, stabilizing the fracture. This procedure does not eliminate other therapeutic options for the patient such as radiation or chemotherapy.
The American Cancer Society estimates 30 to 70 percent of the more than half a million people who die annually of cancer have skeletal metastases and 10 percent of the 700,000 vertebral compression fractures (VCF) that occur each year are believed to be caused by metastatic spine tumors. Skeletal metastases, commonly referred to as spine tumors, are caused when breast, prostate or other primary cancers spread by the bloodstream to the spine, causing vertebrae to weaken and collapse. VCFs can create debilitating back pain, impaired mobility and in some cases, paralysis. In addition to decreasing quality of life, the pain caused by VCFs may make it difficult for many patients to receive their chemo or radiation therapies prescribed by their oncologists.
"Creating a cavity in the tumor results in better outcomes for the patient. Subsequent to reducing the tumor, cement augmentation can be used with more precise cement delivery," said Dawid Schellingerhout, M.D., assistant professor, diagnostic radiology at M.D. Anderson Cancer Center. "Patients who have had vertebroplasty following removal of the tumor material with the Cavity SpineWand typically report significant pain relief - sometimes even complete reduction in pain. In addition to the overall improvement of quality of life, the pain reduction and improved mobility patients experience can be instrumental in helping them comply better with chemotherapy or targeted radiotherapy treatment."
The Cavity SpineWand utilizes CoblationŽ, a patented technology utilizing bipolar radiofrequency to gently and precisely remove soft tissue at low temperatures, generally 40 to 70 degrees Celsius. In this spine procedure, an interventional neuroradiologist or neurosurgeon in consultation with a radiation oncologist, creates a small incision and inserts a cannula to access the affected area within spine. The Cavity SpineWand is inserted through the cannula under radiographic guidance and is activated once it reaches the tumor. A small, highly localized plasma cloud removes tumor material while minimizing damage to surrounding healthy tissue.
"This is a significant step in our mission of developing innovative therapies to improve the quality of lives of the thousands of people living with cancer," said Jim Pacek, Vice President of ArthroCare Interventional Therapies, a newly created division focused on oncology. "This FDA clearance represents the first time a company has been allowed to market a device targeted specifically to remove malignant tissues in the vertebrae. Often, these tumors cause painful vertebral compression fractures. We believe the Cavity SpineWand will be a valuable tool for physicians in their effort to provide improved outcomes for this patient population."
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 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-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.
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