Registry shows positive outcomes for the Codman Enterprise device

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New registry data shows 81% of patients had 90% or higher aneurysm occlusion after 21 months and only 8.3% required retreatment after stent-assisted coil embolization with the Codman Enterprise Vascular Reconstruction Device (VRD) and Delivery System (Codman Neurovascular). 

The registry data was published in the August edition of Neurosurgery, the official journal of the Congress of Neurological Surgeons (CNS).


The registry also found that 90% of patients had modified Rankin Scale (mRS) scores of two or less at last follow-up, meaning the vast majority were independent and had no significant disabilities almost two years after treatment with the device. The mRS score is a measure of the degree of disability or dependence after stroke. The lower the score, the less disability or dependence. The disease/treatment related mortality rate was 0.5%, and the all-cause mortality rate was 1.5%.


The 229-patient retrospective registry included data from nine high-volume neurointerventional centres in the United States and Puerto Rico. Thirty-two of the patients had ruptured aneurysms. On average, patients were 57 years old at the time of treatment and had a 9.2mm aneurysm.


“These data suggest that physicians are continuing to improve their ability to treat wide-necked cerebral aneurysms. There were less patients requiring retreatment than have been previously seen in other studies and higher rates of progressive occlusion over time,” said J Mocco, associate professor of Neurological Surgery, Radiology and Radiological Sciences, Vanderbilt University Medical Center and a co-author of the paper in
Neurosurgery.


Codman received humanitarian device exemption approval for the Codman Enterprise VRD from the FDA in 2007. It is authorised by Federal Law for use with embolic coils for the treatment of wide-neck, intracranial, saccular or fusiform aneurysms arising from a parent vessel with a diameter of ≥2.5mm and ≤4mm. The product received the CE mark approval in 2006.


Neurointerventional centres participating in the registry include: University at Buffalo, University of Florida, University of Cincinnati, West Virginia University, University of Puerto Rico, Albany Medical Center Hospital, Capital Health System, University of Texas Southwestern, and Mayo Clinic.

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