Magellan Spine Technologies, Inc. announced the first human implant of its DART (Disc Annular Repair Technology) System for use after lumbar discectomy procedures. This initial clinical use follows European CE Mark clearance of the DART System in April 2009.
This first of its kind implant was performed by Drs. Juan Dipp and Ricardo Flores at Hospital Y Centro Medico Del Prado in Tijuana, Mexico. Following a standard discectomy procedure for a lumbar disc herniation, the patient was implanted with the Magellan DART device. The device is designed to prevent recurrent disc herniation and maintain disc height.
Commenting on the procedure Dr. Dipp stated, “The DART implantation did not alter the discectomy procedure and was easy to complete. Upon implantation, the DART device sealed the annular defect and increased the patient’s disc height. The patient was discharged less than 24 hours from surgery, has reported no pain and returned to normal activities within the first week.” Dr. Dipp is an orthopedic surgeon and the principal investigator for the clinical evaluation of the Magellan DART device.
The DART is a unique implant that provides a simple and quick seal of the annulus following a standard lumbar discectomy procedure. The unique design and implantation method of the DART provides distinct advantages over other non-fusion lumbar spinal implants. When implanted, the DART is placed near the central axis of rotation along the posterior edge of the vertebral body. The device is aligned with the vertebral body load column, the strongest of the three primary spinal vertical load columns and is secured in place at the apophyseal ring. The DART has structural integrity similar to interbody fusion devices and provides support to maintain disc height.
Commenting on the first human implantation of Magellan’s DART System, Jeff Valko, Chief Executive Officer said, “We are very pleased with the acute results of the first implantation of the DART. The DART represents a novel step forward in the treatment of the spine. Magellan’s device will enable physicians to reduce the risk of reherniation and disc height loss which can lead to pain and degeneration of adjacent segments of the spine.
The company plans to initiate a limited European clinical evaluation late in 2009 followed by commercialization in 2010.”