Registry Supports Codman Enterprise System to Treat Cerebral Aneurysms

September 17, 2012—Codman Neurovascular, Inc., a unit of Codman & Shurtleff, Inc. (Raynham, MA) announced that 21-month data from a registry evaluating the Codman Enterprise vascular reconstruction device (VRD) and delivery system were published by Karl M. Fargen, MD, et al in Neurosurgery.

The company advised that the Codman Enterprise VRD self-expanding stent and delivery system received a Humanitarian Device Exemption (HDE) approval from the US Food and Drug Administration in 2007 and CE Mark approval in 2006.

According to the company, the 229-patient retrospective registry included data from nine high-volume neurointerventional centers in the United States and Puerto Rico. Thirty-two of the patients had ruptured aneurysms. The average age of the patients was 57 years. The average aneurysm size at the time of treatment was 9.2 mm.

Codman stated that the data showed that after 21 months, 81% of patients had 90% or higher aneurysm occlusion and 8.3% required retreatment after stent-assisted coil embolization. The registry also found that 90% of patients had modified Rankin Scale (mRS) scores ≤ 2 at last follow-up, meaning the vast majority were independent and had no significant disabilities almost 2 years after treatment with the device. The disease/treatment related mortality rate was 0.5%, and the all-cause mortality rate was 1.5%.

“These data suggest that physicians are continuing to improve their ability to treat wide-necked cerebral aneurysms,” commented investigator J. Mocco, MD, in Codman's press release. Dr. Mocco is Associate Professor of Neurological Surgery, Radiology and Radiological Science at Vanderbilt University Medical Center. “There were less patients requiring retreatment than have been previously seen in other studies and higher rates of progressive occlusion over time."

Codman & Shurtleff is part of DePuy Synthes Companies of Johnson & Johnson (New Brunswick, NJ).