Navigation Links
Registry Data Shows 90% Of Patients Independent, Free Of Significant Disabilities After Treatment With Codman System For Wide-necked Aneurysms
Date:9/18/2012

RAYNHAM, Mass., Sept. 18, 2012 /PRNewswire/ -- 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. Visit www.codman.com and www.depuysynthes.com for more information.

*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.


'/>"/>
SOURCE Codman & Shurtleff, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Cardiac Science to Supply Q-Tel Data to AACVPR Cardiac Rehabilitation Registry
2. Eleven Integrated Health Systems Form Largest Private-Sector Diabetes Registry in United States
3. Boehringer Ingelheim Announces Launch of GLORIA™-AF Registry in Newly-Diagnosed Patients with Non-Valvular Atrial Fibrillation
4. Remedy Informatics Cardiovascular Registry Selected by World-Renowned Cleveland Clinic Heart and Vascular Institute
5. Fenwick & West Life Science Venture Financing Survey Shows Mild Improvement in Valuations Amid Overall Difficult Financing Environment
6. New Analysis Shows Illicit Drug Use May Vary by Payer Type: Detection Rates as High as 17 Percent
7. Sosei Group Corporation: Data at ERS Shows Efficacy of Once-daily COPD Portfolio Versus Comparators, Further Establishes Dual-bronchodilator QVA149
8. New Study in The Journal of Maternal-Fetal and Neonatal Medicine Shows Fetal Cell-Free DNA in Maternal Blood Unaffected by Trisomy Risk
9. Unprecedented Study shows Berlin Heart device provides life-saving "bridge" for young children and babies
10. New Viviscal Research Shows Hair Loss at the Root of Womens Sexual Confidence
11. OncoSec OMS ElectroChemotherapy for Head and Neck Cancer Shows Enhanced Quality of Life in Two Randomized Phase III Studies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 23, 2016 The vast majority of dialysis ... facility.  Treatments are usually 3 times a week, with ... including travel time, equipment preparation and wait time.  This ... grueling for patients who are elderly and frail.  Many ... and rehabilitation centers for some duration of time. ...
(Date:6/23/2016)... Tenn. , June 23, 2016 /PRNewswire/ ... automating, integrating and transforming the patient payment ... of several innovative new products and services ... of its revenue cycle offerings. These award-winning ... more efficient workflows, remain compliant in an ...
(Date:6/23/2016)... , June 23, 2016  The National ... has joined the health policy research organization as ... Romano , MD, senior vice president and chief ... company,s representative on the NPC Board of Directors. ... pleased that Mallinckrodt has joined us in support ...
Breaking Medicine Technology:
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, was ... his family verbally and physically. , “When something upset him, he couldn’t control his emotions,” ... He would throw rocks at my other children and say he was going to kill ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, P.A. announced that ... chosen by their peers for this recognition are considered among the top 2 percent ... special honors as members of this year’s Legal Elite Hall of Fame: Miami ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA is ... Road To Recovery® program to drive cancer patients to and from their cancer treatments. ... the highest quality of life and ongoing independence. Getting to and from medical ...
(Date:6/24/2016)... Plano, TX (PRWEB) , ... June 24, 2016 , ... ... taking part in Genome magazine’s Code Talker Award, an essay contest in which patients ... for an award to be presented at the 2016 National Society of Genetic Counselors ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... Living, is proud to recognize Dr. Barry M. Weintraub as a prominent plastic ... most beautiful women in the world, and the most handsome men, look naturally ...
Breaking Medicine News(10 mins):