Enrollment in patient study to evaluate Magellan DART System for Annular Repair completed

Mar 16 2010

Magellan Spine Technologies, Inc. today announced it had completed enrollment in a twenty patient study to evaluate the Magellan DART (Disc Annular Repair Technology) System for Annular Repair following lumbar discectomy procedures. This first study demonstrates evidence that the DART technology is safe and patients implanted with the DART have excellent outcomes approaching one year follow-up.

“The device gets integrated into the disc space and maintains height without fusing the adjacent vertebra. The patients return to normal activities and have less risk for repeat surgery.”

This first of its kind study was performed by Dr. Juan Dipp, Hospital Y Centro Medico Del Prado in Tijuana, Mexico, and Dr. Ricardo Flores, Almater Hospital, Mexicali, Mexico. The study design included patients with single level visually confirmed lumbar disc herniation that had failed conservative therapy. Patients were admitted into the hospital on the day of surgery, and had baseline patient assessments prior to surgery. Surgeries were performed minimally invasively or by open techniques. Following discectomy, the patients were implanted with the Magellan DART device. The DART implantation only increased procedure time by an average of ten minutes. All patients were discharged one day following surgery.

Upon follow-up, patients had significant improvement in routine pain score evaluations. Radiographic and MR image analysis confirmed that there were not any patient recurrent disc herniations or evidence of disc height loss during follow-up periods up to one year following surgery.

Commenting on the results, Dr. Flores stated, “The DART is easy to use following a discectomy and seals the annular wall defect. The patients have great outcomes and I now use it for all lumbar discectomy candidates.” Dr. Dipp added, “The device gets integrated into the disc space and maintains height without fusing the adjacent vertebra. The patients return to normal activities and have less risk for repeat surgery.”

The study results will be presented at the Spine Arthroplasty Society Conference, April 27-30, 2010.

The DART - Disc Annular Repair Technology

The DART is a simple peek implant that provides for annular repair following a lumbar discectomy procedure. The unique DART design allows for simple implantation, secure retention, and provides distinct advantages over other non-fusion lumbar spinal implants.

Commenting on the study results for Magellan’s DART System, Michael Henson, Magellan Chairman, said, “We are encouraged by the positive patient outcomes achieved following DART implantation. These findings support DART’s objective of reducing recurrent disc herniations and disc height loss which are reported to lead to pain and degeneration of adjacent segments of the spine. With these results and our recent CE-Mark approval, we will plan to move forward with a European clinical evaluation and product launch in late 2010.”