ArthroCare's Parallax Acrylic Resin with TRACERS-Ta Receives FDA Clearance for Vertebroplasty and Kyphoplasty; New Product Strengthens Company's Leading Line of Cement Products.AUSTIN, Texas -- ArthroCare(R) Corp. (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, received notice 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. ) today that its 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. (R) Acrylic Resin with TRACERS(R)-Ta Bone Cement Opacifier o·pac·i·fi·er n. A chemical agent added to a material, such as rocket propellant, to make it opaque. has been cleared for the fixation of pathological fractures of the vertebral ver·te·bral adj. 1. Of, relating to, or of the nature of a vertebra. 2. Having or consisting of vertebrae. 3. Having a spinal column. body using vertebroplasty or kyphoplasty procedures. "The clearance of Tantalum opacified cement for use in vertebroplasty and kyphoplasty procedures further strengthens ArthroCare's position as a leading innovator in the treatment of spine diseases," said David Applegate, vice president and general manager of ArthroCare Spine. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma hemangioma Congenital benign tumour made of blood vessels in the skin. Capillary hemangioma (nevus flammeus, port-wine stain), an abnormal mass of capillaries on the head, neck, or face, is pink to dark bluish-red and even with the skin. Size and shape vary. ), and malignant lesions (metastatic cancers, myleoma). It is estimated that over 750,000 people a year are diagnosed with vertebral compression fractures (National Osteoporosis Society). This product is designed to enhance the physician's ability to track the flow of bone cement under fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope. fluo·ros·co·py n. Examination by means of a fluoroscope. Also called radioscopy. and consists of premeasured Polymethyl-methacrylate (PMMA PMMA polymethyl methacrylate. ), Barium Sulfate and proprietary tantalum disk opacifiers. These particles create visible dark dots that clearly show cement flow and placement within the bone cavity, increasing patient and procedure safety. "The addition of Tantalum as an opacifier in acrylic bone cement may improve the safety profile for patients undergoing vertebroplasty and kyphoplasty procedures. As the only tantalum opacifed cement approved for these procedures, Parallax Acrylic Resin with Tracers is important and extremely helpful for cases where imaging and visibility of the opacified cement is critical," stated Dr. Huy M. Do, Interventional Neuroradiologist neuroradiologist A radiologist specialized in using various imaging techniques to diagnose diseases of the nervous system , Associate Professor of Radiology and Neurosurgery, Stanford University Medical Center Stanford University Medical Center (Stanford Hospital & Clinics) is one of four hospitals affiliated with Stanford University and Stanford University School of Medicine, along with the Lucile Packard Children's Hospital, the Veteran's Administration Hospital in Palo Alto, and Santa . ArthroCare's line of bone cement products, including Parallax Acrylic Resin with TRACERS-Ta provides key advantages for increasing procedure flexibility including: --A 12 to 15 minute work time. --All-in-one package. Add monomer and mix together. --Optimum opacification without altering compression strength. 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 and Parallax spine products, to complement Coblation within key indications. You can learn more about ArthroCare Spine at www.arthrocare.com. 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 2005 and 2006, 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 March 31, 2005 and Form 10-K for the year ended Dec. 31, 2004. 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. |
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