ArthroCare Receives FDA Clearance to Treat Malignant Lesions in the Spine.AUSTIN, Texas -- ArthroCare (Nasdaq:ARTC ARTC Arthrocare Corp (stock symbol) ARTC Australian Rail Track Corporation ARTC Air Route Traffic Control ARTC Association de la Recherche Theatrale au Canada ARTC Andean Root and Tuber Crops ), 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its Cavity SpineWand([R]) to reduce malignant lesions within the vertebrae Vertebrae Bones in the cervical, thoracic, and lumbar regions of the body that make up the vertebral column. Vertebrae have a central foramen (hole), and their superposition makes up the vertebral canal that encloses the spinal cord. . 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 American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, 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 VCF Valencia Club de Futbol (Spanish soccer team) VCF Virtual Career Fair VCF Value City Furniture VCF Virtual Case File (FBI automated case management system) VCF Voltage Controlled Filter ) 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 de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction 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 che·mo n. Chemotherapy or a chemotherapeutic treatment. 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 Coblation[R], 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 neuroradiologist A radiologist specialized in using various imaging techniques to diagnose diseases of the nervous system or neurosurgeon neurosurgeon a physician who specializes in neurosurgery. neurosurgeon A surgeon specialized in managing diseases of the brain, spine and peripheral nerves Meat & potatoes diseases Brain tumors, spinal cord disease Salary $245K + 15% bonus. in consultation with a radiation oncologist, creates a small incision and inserts a cannula cannula /can·nu·la/ (kan´u-lah) a tube for insertion into a vessel, duct, or cavity; during insertion its lumen is usually occupied by a trocar. can·nu·la or can·u·la n. pl. to access the affected area within spine. The Cavity SpineWand is inserted through the cannula under radiographic radiographic (rā´dēōgraf´ik), adj relating to the process of radiography, the finished product, or its use. 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." 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 ENT ears, nose, and throat (otorhinolaryngology). ENT abbr. ear, nose, and throat ENT ear, nose and throat. ENT Ears, nose & throat; formally, otorhinolaryngology ); cosmetic; urologic and gynecologic gynecologic /gy·ne·co·log·ic/ (gi?ne-) (jin?e-kah-loj´ik) pertaining to the female reproductive tract or to gynecology. procedures. ArthroCare also has added a number of novel technologies to its portfolio, including Opus Medical sports medicine, Parallax parallax (pâr`əlăks), any alteration in the relative apparent positions of objects produced by a shift in the position of the observer. In astronomy the term is used for several techniques for determining distance. 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 Words and Phrases® A multivolume set of law books published by West Group containing thousands of judicial definitions of words and phrases, arranged alphabetically, from 1658 to the present. . Actual results may differ materially from management expectations. |
|
||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion