Raymedica Inc, a medical device developer and manufacturer, has received a Notice of Allowance for its 14th U.S. patent on the PDN prosthetic disc nucleus device and related technology, titled "A Prosthetic Disc Nucleus with Shape Change Characteristics." The company has also filed a patent for a novel spinal implant device which is intended to seal the opening in a spinal disc after a discectomy procedure. Additional patents are pending on the PDN device and improved manufacturing methods of the company's proprietary hydrogel technology.
"The new patent Notice of Allowance describes a unique feature of the PDN device as we currently manufacture it - our ability to produce the hydrogel PDN implant in a very compact size and shape, which expands and assumes its larger functional shape after implantation into a patient," said Tony Phillips, Raymedica president and chief executive officer. Raymedica also owns 20 international patents on its PDN device technology while another 22 patents are pending.
Raymedica manufactures the PDN device in 15 different sizes and shapes, so surgeons can select devices that closely fit the patient's spinal disc space. Final manufacturing steps consist of dehydrating and compressing the implants. A compact size allows surgeons to implant the device through a small incision. After implantation, the device absorbs fluid from the body and expands substantially in size and shape within the disc space.
Raymedica recently submitted a patent for a new spinal implant device, the NuSeal nucleus closure device, that is intended to seal a herniation or incision in a spinal disc after a discectomy, or removal of the disc nucleus. Currently, there are no means of repairing or closing the incision, which often results in unsatisfactory patient results. The closure device addresses a potential market of more than 500,000 lower back surgical procedures in the United States each year.
The PDN 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.