FDA Approves Knee-injury Device for the Irreparable Meniscus Tears

by VR Sreeraman on  October 3, 2007 at 5:16 PM Research News   - G J E 4
FDA Approves Knee-injury Device for the Irreparable Meniscus Tears
US agency the Food and Drug Administration (FDA) has approved a new knee-surgery device developed by researchers at the University of Missouri-Columbia which helps in repairing meniscus tears for use in humans.

The device, called BioDuct Meniscal Fixation Device, helps repair meniscus tears, which were previously defined as irreparable.

The meniscus, a padding tissue that provides shock absorption and joint stability in the knee, is essential for normal knee function.

Previous treatment options forced surgeons to completely remove the damaged portion of the meniscus, which led to painful, debilitating arthritis in the knee.

"In the past, when faced with meniscus injuries, surgeons were often forced to completely remove the torn meniscal cartilage, leaving a deficient knee that was doomed to develop arthritis. With the BioDuct Meniscal Fixation Device, surgeons will be able to repair torn menisci and induce healing. People with meniscus injuries now have a better future ahead," said Herb Schwartz, president and CEO of Schwartz Biomedical, LLC.

The device was developed by Schwartz along with James Cook, MU professor of veterinary medicine and surgery and William C. Allen Endowed Scholar for Orthopedic Research in MU's College of Veterinary Medicine.

When meniscus function is deficient, bone rubs on bone and arthritis is likely to develop and progress. Because two-thirds of the meniscus is avascular (lacks a blood supply), a tear in that region will not repair itself.

The new device will transport blood and cells from the vascular portion of the knee to the avascular portion of the meniscus. Supplied with blood and cells for healing, the previously untreatable meniscal tear now has the potential for allowing the knee joint to be saved.

In order to test the new device, the research team performed the BioDuct surgery on 25 dogs that had worst-case scenario meniscal tears. With the new device, the meniscus in the dogs' knees had complete or partial repair after a few weeks in all cases.

"Currently, there are no other devices that can provide improved fixation over time. Therefore, the BioDuct device is set apart from the rest of the field," Schwartz said.

The findings of the research showed that the new device will significantly improve healing of avascular meniscal tears both biologically and biomechanically, which should lessen the long-term effects of meniscus injuries, including osteoarthritis.

"The BioDuct device could impact the industry by improving repairs of the meniscus to such an extent that fewer patients develop arthritis that results from removing the meniscal tissue. Thus, with fewer patients developing arthritis, the result could be fewer total joint replacements or at least delaying the need for a total joint replacement," Schwartz said.

The recent findings are published in the American Journal of Sports Medicine.

Source: ANI

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