Raymedica Inc has introduced the Company's new PDN-SOLO XL prosthetic disc nucleus device. The PDN-SOLO XL device is intended for use in patients with larger disc spaces. Similar to the PDN-SOLO device, the new device is a single-unit implant designed for the treatment of low-back pain that has not responded to conservative therapy and as an alternative to more invasive spine surgery procedures.
"In September 2002 Raymedica successfully introduced the PDN-SOLO device, our first single-unit implant. Over 700 patients worldwide have received a PDN-SOLO implant with great clinical success," said Tony Phillips, Raymedica President and Chief Executive Officer. "With the addition of the PDN-SOLO XL device, patients with larger disc spaces now have a partial disc replacement option in the form of a single-unit implant. The benefits of the new single-unit implant are identical to those currently offered by PDN-SOLO device, which includes reduced operating room time, ease of surgical technique and greater surgeon satisfaction."
The PDN-SOLO XL device was designed as a single-unit implant within the spinal disc nucleus for patients with large disc spaces suffering from low-back pain that has not responded to conservative care. Alternative surgical treatments include spinal fusion and total disc replacement. The PDN-SOLO XL device contains the same proprietary hydrogel material as previous models. Once implanted, the PDN-SOLO XL device begins to absorb fluid from the body, expanding both vertically and horizontally to relieve pain and maintain or increase disc height, thus restoring normal biomechanics.
The PDN-SOLO XL device is covered by the CE Mark approval Raymedica received for the original PDN device in 1999.