Back Pain Relief Goes International

Eden Prairie, MN - Dynamics Inc. announced that it has received CE Mark approval of its DASCOR Disc Arthroplasty System. The CE Mark allows the company to market the device in any European Union member country and in other selected international markets.

The DASCOR device is a patented spinal disc nucleus implant designed to treat the back pain associated with degenerative disc disease (DDD). Traditionally, patients with DDD and associated lower back pain have undergone spinal fusion surgery and, more recently, total disc replacement. The DASCOR device offers a less invasive surgical option that preserves the disc anatomy and restores stability and normal motion to the spine, eliminating the need for fusion.

Commenting on the approval, Steven J. Healy, president and chief executive officer of Disc Dynamics Inc., said: "Receiving the CE Mark is a significant milestone for Disc Dynamics Inc. It's a clear validation of the rigorous research, design and testing activities completed over the last three years to develop this important new device to treat chronic low back pain."

Healy indicated that the company will now pursue a launch of the DASCOR device at selected centers in Europe. "Initially, our plan includes a careful, investigational approach with a few prominent centers to accumulate additional clinical experience with the device," he said. Disc Dynamics Inc. has filed an Investigational Device Exemption (IDE) for the DASCOR device with the U.S. Food and Drug Administration (FDA).

Treatments of degenerative spine disease represent the fastest-growing segment of the global orthopedic market. Each year hundreds of thousands of patients undergo a surgical intervention to address their chronic and often debilitating low back pain. Many of these procedures include fusion of one vertebra to another to stabilize the spine. Sometimes ineffective, fusion alters the normal biomechanics of the spine, which can create new problems at adjacent vertebral segments, often requiring re-operation.

SOURCE: Disc Dynamics Inc.