Two Studies Show Benefits Of Removing Tumor Tissue In The Spine Prior To Adjuntive Treatments

Main Category: Neurology / Neuroscience
Also Included In: Radiology / Nuclear Medicine
Article Date: 02 Dec 2008 - 6:00 PST

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Two studies, presented this week at the 94th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), concluded a novel technique can improve outcomes for patients with vertebral compression fractures (VCF) caused by malignant tumors in the spine. The American Cancer Society estimates 30 to 70 percent of more than half a million people who die annually of cancer have metastatic disease and 10 percent of the 750,000 vertebral compression fractures that occur each year are caused by metastatic spine tumors.

This new treatment uses a plasma mediated medical device, the Cavity SpineWand®, developed by ArthroCare® Corp to debulk, or reduce, the lesion. Bone cement can be subsequently injected to stabilize the fracture. Stabilization of the fracture helps to ease the pain associated with VCFs. The combined therapies have been successfully used in tandem with radiation and chemotherapy.

One study, led by Mark Perman, M.D., an ArthroCare consultant, examined a synergistic approach to treating VCFs secondary to spinal metastases. The approach consisted of three treatments: removing tumor tissue to create a cavity, filling the cavity with bone cement to stabilize the vertebral body and then treating the tumor with either radiosurgery or external beam radiation to reduce the remaining tumor burden. A separate study by Bassem Georgy, M.D. found removing tumor tissue with the Cavity SpineWand increased control and predictability during cement injection.

"Patients with VCFs are typically in extreme pain and radiation therapy alone, which is critical to treating the cancer, may be ineffective as a palliative option," said Dr. Perman, Chief of Radiosurgery, The CyberKnife Center at North Florida Radiology. "With this synergistic approach, my patients receive quick pain relief and mechanical stability without delaying tumor treatment, which can dramatically improve quality of life."

The study led by Dr. Perman, "Vertebroplasty and Radiation Therapy: Synergistic Treatment of Pathologic Compression Fractures," involved seven patients suffering from painful VCFs. After treatment, all but one patient reported significant pain relief immediately following the treatments which was sustained or reduced further during follow-up with radiation therapy. Pain levels were assessed at three different time points over the course of three months.

In the study "Percutaneous Anterior Column Stabilization in Metastatic Spine Lesions: Value of Plasma-mediated Radiofrequency Ablation and Cement Augmentation," Dr. Georgy, interventional neuro-radiologist and Associate Professor as University of California San Diego, and a consultant to ArthroCare, reported 82.3 percent success in placing bone cement in the anterior 2/3 of the vertebral body, which is commonly believed to be a key factor in stabilizing the spine. The study included 30 patients (34 levels) with 25 (83 percent) reporting pain relief following cement augmentation.

The Cavity SpineWand is a minimally invasive device that uses a plasma based technology called Coblation® to create a cavity in a malignant lesion. The Cavity SpineWand is inserted through a cannula to reach the tumor inside the vertebrae. Once inside, a low-heat, plasma cloud removes tumor tissue while minimizing damage to surrounding healthy tissue. Medical grade bone cement is subsequently injected to stabilize the fracture using the space created by the reduction of the lesion. Following vertebroplasty, patients report significant pain relief, often within 72 hours post procedure.

This minimally invasive procedure is typically performed by a specialist in consultation with a radiation oncologist. Over 200 physicians in the United States have been trained in these treatments to date.

Dr. Perman will present "Vertebroplasty and Radiation Therapy: Synergistic Treatment of Pathologic Compression Fractures" on Tuesday, Dec. 2, 2008, at 10:30 a.m. at S102D. Dr. Georgy will present "Percutaneous Anterior Column Stabilization in Metastatic Spine Lesions: Value of Plasma-mediated Radiofrequency Ablation and Cement Augmentation" on Thurs., Dec. 4, at N226.

About Arthrocare

Founded in 1993, ArthroCare Corp. 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 - Cautionary Statement Regarding Forward-Looking Statements

The information provided in this press release includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, including statements regarding the strength or expected benefits of the Company's technology.

Statements that are not historical facts are forward-looking statements. These statements are based on beliefs and assumptions by management, and on information currently available to management.

Forward-looking statements speak only as of the date they are made, and ArthroCare undertakes no obligation to update any of them publicly in light of new information or future events. A number of important factors could cause actual results to differ materially from those contained in any forward-looking statement. Examples of these factors include, but are not limited to, with respect to the studies mentioned above, the preliminary nature of the studies listed above and the possibility that more studies may be needed, the uncertainty over whether the malignancies treated in the studies mentioned above may return, the possibility that the pain improvement mentioned may not be permanent, the possibility that these studies may not be accepted by insurers or other payors; and generally, the strength of the Company's technology and its continued adoption, unanticipated accounting issues or audit issues regarding the financial data for the periods being restated in the Company's previously announced restatement; the ability of the Company and its independent registered public accounting firm to confirm information or data identified in the review, being overseen by the Audit Committee of the Company's Board of Directors, of the scope and nature of the Company's internal controls (the "Review"); unanticipated issues regarding the Review that prevent or delay the Company's independent registered public auditing firm from relying upon the Review or that require additional efforts, documentation, procedures, review or investigation; the Company's ability to design or improve internal controls to address issues detected in the Review or by management in its reassessment of the Company's internal controls; the impact upon the Company's operations of the Review, legal compliance matters or internal controls, improvement and remediation; difficulties in controlling expenses, including costs of the Review, legal compliance matters or internal controls review, improvement and remediation; the Company's ability to become current in its SEC periodic reporting requirements; the outcome of pending litigation; general business, economic and political conditions; competitive developments in the medical devices market; changes in applicable legislative or regulatory requirements; the Company's ability to effectively and successfully implement its financial and strategic alternatives, as well as business strategies, and manage the risks in its business; the reactions of the marketplace to the foregoing; and other risks and uncertainties discussed more fully in the Company's SEC filings, including those discussed under Item 1A. "Risk Factors" in its Form 10-K for the fiscal year ended December 31, 2007.

ArthroCare Corp.