21-Month Retrospective Registry Data Published in Neurosurgery
RAYNHAM, MA – Sept. 17, 2012 -- New registry data shows 81 percent of patients had 90 percent or higher aneurysm occlusion after 21 months and only 8.3 percent required retreatment after stent-assisted coil embolization with the CODMAN ENTERPRISE® Vascular Reconstruction Device (VRD) and Delivery System.* The registry data was published in the August edition of Neurosurgery, the official journal of the Congress of Neurological Surgeons (CNS), Codman Neurovascular, the manufacturer of the system, announced today.
The registry also found that 90 percent 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 zero point five percent (0.5%), and the all-cause mortality rate was 1.5 percent.
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. On average, patients were 57 years old at the time of treatment and had a 9.2 millimeter 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, MD, Associate Professor of Neurological Surgery, Radiology and Radiological Sciences, Vanderbilt University Medical Center and a co-author of the paper in Neurosurgery.
“This registry data provides clinicians with important information about what can be a difficult to treat condition,” said P. Laxmin Laxminarain, Worldwide President of Codman & Shurtleff, Inc. “We are pleased that this registry data is consistent with previous short and mid-term studies on the device.” Codman received Humanitarian Device Exemption (HDE) approval for the CODMAN ENTERPRISE VRD, a self-expanding stent and delivery system, from the U.S. Food and Drug Administration (FDA) in 2007 and CE Mark approval in 2006. HDE approval is granted for Humanitarian Use Devices (HUD) that are intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in less than 4,000 individuals in the United States per year and for which no comparable device is available. HDE approval is based on safety and probable benefit; HDEs are exempt from the requirement to provide a reasonable assurance of effectiveness.
Neurointerventional centers 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. About Codman & Shurtleff, Inc.
Codman is a global neurosurgery, neurovascular and neuromodulation company that offers a broad portfolio of devices for drug delivery, hydrocephalus management, neuro intensive care and cranial surgery as well as aneurysm coils, vascular reconstruction devices and other technologies used in the endovascular treatment of cerebral aneurysms and stroke. Codman is part of DePuy Synthes Companies of Johnson & Johnson.
*HUMANITARIAN DEVICE (USA ONLY):The CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System is authorized 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. Wide-neck is defined as having a neck width ≥4mm or a dome-to-neck ratio <2. The effectiveness of this device for this use has not been demonstrated.