Raymedica Inc has received authorization from the Food and Drug Administration (FDA) to include the PDN-SOLO prosthetic disc nucleus device in its U.S. clinical study. Patients with chronic low back pain due to degenerative disc disease who have not responded well to non-surgical alternatives will be sought for study enrollment. The U.S. clinical study is being conducted in Norfolk, Virginia, Minneapolis, Minnesota, and Dallas, Texas.
"The PDN-SOLO device was developed over the past two years as a result of our experience with the original PDN device design in clinical studies in Europe and Latin America," said Tony Phillips, Raymedica's President and Chief Executive Officer. "The original device was required to be implanted in pairs (two devices necessary for implant in each diseased spinal disc) due to limitations on the size of the surgical access site. Each unit of the paired device could be implanted through a small incision, then the two units were bound together once inside the diseased spinal disc. However, our manufacturing expertise has grown over the years so that we are now able to manufacture a PDN-SOLO device in the same size as the original PDN device, but upon implantation, the PDN-SOLO device expands in size to nearly that of the original paired devices," he added. This feature simplifies the surgical procedure and lessens the operating time significantly, without sacrificing the effectiveness of the implant.
Receiving authorization from the FDA to include the PDN-SOLO device in the U.S. clinical study is a step forward for the Company, in that the most advanced version of the PDN device will now be available for patients who elect to become part of the clinical evaluation. Surgeons in Europe, Asia and Latin America have been using the PDN-SOLO device since mid-year in 2002 with excellent clinical results and substantially reduced operating room time. To date, approximately 750 patients have received a PDN-SOLO implant in international communities with continued strong clinical outcomes and significant improvement in both surgeon satisfaction and safety profile as compared to the original paired PDN device design.
The PDN-SOLO device is comprised of a hydrogel material designed to replace the function of a failed spinal disc nucleus. To treat low back pain, a single PDN-SOLO device is implanted in the center of the spinal disc. The device is designed to support the bones of a patient's spine while allowing for more normal flexibility and movement than spinal fusion, the current established surgical treatment, in which adjacent vertebrae are fused together.