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Researchers Report that Pain Management SInergy Cooled Radiofrequency System From Kimberly-Clark Health Care Provides Lasting Pain Relief, and Demonstrates an Alternative Treatment for Chronic Sacroiliac Joint Pain

Clinical Trial Data Presented at American Society of Interventional Pain Physicians (ASIPP) Annual Clinical Meeting Updates Cooled Radiofrequency Technology Treatment Data


News provided by

Kimberly-Clark Corporation

Jul 14, 2011, 03:43 ET

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ROSWELL, Ga., July 14, 2011 /PRNewswire/ -- Kimberly-Clark Health Care announced the results of clinical trial data presented in late June at the annual meeting of the American Society of Interventional Pain Physicians (ASIPP) in Arlington, VA.

The study of the company's SInergy Cooled Radiofrequency System for pain management compared treatment of 34 patients to a sham group of 17 patients all suffering from Sacroiliac joint (SIJ) pain, which is believed to account for between 18 and 30 percent of all chronic axial lower back pain. The previously released three-month follow-up data was awarded the best clinical paper in 2010 by the International Spine Intervention Society (ISIS). Additional six- and nine-month primary efficacy data demonstrated durability of the three-month data. At three months follow-up, all patients in the control group were offered the opportunity to switch over to active treatment.

"These results demonstrate the significant capabilities of the SInergy System," said lead clinical investigator Andrew M. Gross M.D., now of the Orthopedic Center of Florida in Fort Myers. "The system provides an efficacious and safe solution for patients who suffer from chronic SIJ pain. These results follow a series of other studies in which cooled radiofrequency probes have shown promise, and the door is now open to a whole new category of therapy for what has been an extremely challenging condition to treat."

About the Clinical Trial

Baylis Medical Company sponsored the trial and was the original developer of the SInergy System, which was acquired by Kimberly-Clark Health Care in 2009.

About the pain management SInergy System

The SInergy System, a cooled radiofrequency energy device, is indicated for creating RF lesions in nervous tissue. The procedure is known as lateral branch denervation and ablates the afferent nociceptive nerves that originate in the sacroiliac joint and surrounding tissue. These nerves are known to be responsible for idiopathic sacroiliac pain. The procedure is minimally invasive and uses internally-cooled radiofrequency probes to create controlled, repeatable, large volume, spherical lesions that are optimized in size and position to compensate for the variable nerve course.

Kimberly-Clark in the Healthcare Environment

Around the world, medical professionals turn to Kimberly-Clark for a wide portfolio of solutions that improve the health, hygiene and well-being of their patients and staff. As part of their healing mission, caregivers rely on Kimberly-Clark to deliver clinical solutions and educational resources that they can depend on to prevent, diagnose and manage a wide variety of healthcare-associated infections. This more than $1 billion global enterprise of Kimberly-Clark Corporation holds the No. 1 or No. 2 market share position in several categories, including infection control solutions, surgical solutions, pain management and digestive health. And throughout the care continuum, patients and staff alike trust Kimberly-Clark medical supplies and devices, KLEENEX tissues, KIMBERLY-CLARK PROFESSIONAL skin care products and SCOTT towels for day-to-day needs. For more information, visit http://www.kchealthcare.com

SOURCE Kimberly-Clark Corporation

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