AUSTIN, Texas–(BUSINESS WIRE)–ArthroCare Corp. (NASDAQ: ARTC), a leader in developing state-of-the-art, minimally invasive surgical products, announced today the publication of an important clinical trial demonstrating that patients treated with ArthroCare’s Plasma Disc Decompression (PDD) products experienced reduced pain and better quality of life scores compared to patients treated with the current standard care, epidural steroid injections.
The multi-center study, which is titled “Plasma Disc Decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: A prospective, randomized, controlled trial,” was published in the April 2010 issue of the Journal of Neurosurgery: Spine.
This prospective, controlled and randomized study enrolled 90 patients (18 to 66 years old) with low back pain associated with contained herniated discs and who had previously failed conservative care and one epidural steroid injection. Low back pain can be caused when a disc becomes injured and bulges into adjacent nerves in the spine. These patients are usually treated with a regimen of medical care and physical therapy which will reduce the pain for many. However for a significant portion of patients, the pain will persist and is later treated with injection of steroids or surgery. Epidural steroid injections are considered to be the standard care for patients experiencing low back pain caused by contained herniated discs.
Patients were placed randomly into two groups, a PDD arm and an epidural steroid injection arm and were later evaluated for pain reduction and quality of life over a two-year period. The study concluded that patients in the PDD group experienced clinically important improvements compared to patients in the epidural steroid injection group. After a two-year follow-up period, 56 percent of patients in the PDD group did not have a subsequent secondary procedure, compared with only 28 percent of the patients in the epidural steroid group.
Peter C. Gerszten, MD, MPH, Associate Professor of Neurological Surgery, at the University of Pittsburgh Medical Center, and principal investigator of the clinical study commented, “This study provides evidence that patients with low back pain associated with a contained disc herniation achieve better outcomes with Plasma Disc Decompression as compared to conventional treatment with epidural steroid injections.”
ArthroCare’s PDD products are minimally invasive and can be used in an out-patient basis. The products are used surgically to remove a tiny portion of a contained herniated disc. The products are recommended for those patients with contained herniated discs that have not ruptured. More aggressive surgical options have included laminectomy where portions of a vertebra are removed, or discectomy where most or the entire disc is removed.
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 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 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 other technologies to its portfolio, including Opus Medical sports medicine, Parallax spine and Applied Therapeutics ENT products, to complement Coblation within key indications.
The information provided herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Statements that are not historical facts are forward-looking statements. Forward-looking 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 the Company undertakes no obligation to update any of them publicly in light of new information or future events. Additional factors that could cause actual results to differ materially from those contained in any forward-looking statement include, without limitation: the ability of the Company to fulfill its obligations with respect to the rights of the holders of the Series A Convertible Preferred Stock, including but not limited to the redemption rights and registration rights of the holders of the Series A Convertible Preferred Stock; the resolution of litigation pending against the Company; the Company’s ability to design or improve internal controls to address issues detected in its reviews of internal controls and insurance reimbursement practices or by management in its reassessment of the Company’s internal controls; the impact upon the Company’s operations of legal compliance matters or internal controls review, improvement and remediation; the ability of the Company to control expenses relating to legal compliance matters or internal controls review, improvement and remediation; the Company’s ability to remain current in its periodic reporting requirements under the Exchange Act and to file required reports with the Securities and Exchange Commission on a timely basis; the results of the investigations being conducted by the Staff of the Division of Enforcement of the Securities and Exchange Commission and the United States Department of Justice; the impact on the Company of additional civil and criminal investigations by state and federal agencies and civil suits by private third parties involving the Company’s financial reporting and its previously announced restatement and its insurance billing and healthcare fraud-and-abuse compliance practices; the ability of the Company to attract and retain qualified senior management and to prepare and implement appropriate succession planning for its Chief Executive Officer; 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; and the reactions of the marketplace to the foregoing.