Magellan Spine Technologies, Inc. announced today receipt of the CE Mark for the Company’s DART™ Disc Annular Repair Technology System. This patented technology is used to seal the access site in the annulus fibrosus following lumbar spine microdiscectomy. The CE Mark allows Magellan to market the DART System in the European Union and other countries that recognize the CE Mark for distribution purposes.
Lower back pain is the number one cause for physician office visits and the most common cause for surgical intervention. Lumbar spine vertebral disc herniation compresses nerve roots and results in lower back pain, radicular pain or numbness in the legs. A microdiscectomy surgical procedure is performed to remove the herniated disc bulge, resulting in nerve decompression and pain relief. Spinal microdiscectomy is one of the few surgical procedures where the site of access is left open, which can result in reherniation at the surgical site. It has been reported that up to 27% of discectomy patients experience recurrent pain and require additional surgical procedures within 2 years due to reherniation.
The DART – Disc Annular Repair Technology
The DART is a unique implant that provides a simple, quick and safe closure of the annulus following a standard lumbar microdiscectomy procedure. The DART is a totally unique spinal device that is implanted differently than conventional spinal products. This unique design and implantation method provides several 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 most dense bone of the vertebral body.
Commenting on the CE Mark for Magellan’s DART System, Jeff Valko, Chief Executive Officer said, “We are very pleased to have received the CE Mark for the DART. The DART device 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 may 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.”
Magellan Spine Technologies, Inc., incubated in 2007 by the MedFocus Fund, is a private medical technology firm located in Irvine, California. Magellan is developing the DART Technology to provide spinal disc annular repair following lumbar spine discectomy procedures.
Source: Magellan Spine Technologies