NEW

OR Today, 3M Healthcare Webinar Delivers ‘Great Content’

Kimberly Prinsen, RN, MSN, technical service specialist in the medical solutions division of 3M, explained basic considerations to surgical wound management and how looking deeper than the surface of the skin can protect the patient from complications.

ETHICON LAUNCHES VISTASEAL FIBRIN SEALANT

Many patients today are entering the operating room with multiple factors that can cause disruptive bleeding during surgery, which can be challenging to manage and potentially dangerous. To help address this, Johnson & Johnson Medical Devices Companies* announced...

Going digital: Using real data to prevent infection

By Dustin Rahlf, Director of Healthcare Digital Solutions at Ecolab While AI & robot enabled surgeries are capturing headlines, real-time digital dashboards and predictive analytics may be the overshadowed sidekick that enables a safer operating room (OR). It is...

AORN Updates Guideline on Sterilization Packaging

By Susan Klacik The primary objective of sterilization packaging is to maintain the sterile integrity of the packaged contents until they are used. Many factors influence this outcome and the Association of periOperative Registered Nurses’ (AORN’s) newly updated...

Data Shows Vascular Reconstruction Device Effective for Aneurysm Occlusion

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).

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 0.5 percent, 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 widenecked 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, a neurosurgery, neurovascular and neuromodulation company, 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.

Previous

Next

Submit a Comment

Your email address will not be published. Required fields are marked *

X