Navigation Links
FDA Expands Approved Use For Carotid Stent
Date:5/6/2011

SILVER SPRING, Md., May 6, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved an expanded indication that will allow a new group of patients at risk of stroke due to clogged neck arteries to be treated with the RX Acculink carotid stent.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The carotid arteries on each side of the neck bring blood to the brain. The blood flow in the arteries can become partially or totally blocked by fatty material called plaque. Lack of blood flow to the brain can result in a stroke.

In 2004, the FDA approved the RX Acculink for patients with clogged carotid arteries who were at high risk of complications if they underwent a surgical treatment known as carotid endarterectomy, a procedure that involves cutting open the neck artery and scraping out the plaque.

Today's action expands the indication for use of the stent to include all patients with clogged carotid arteries who are at risk for stroke, not just those who are not good candidates for surgery.

With the RX Acculink, physicians insert a catheter into the groin and thread it up to the affected neck artery. Physicians then place a small mesh tube, called a stent, into the artery to keep the artery open.

"Expanded access to RX Acculink means patients and their health care providers have another option for treating clogged neck arteries," said Christy Foreman, M.B.E., director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health.

The FDA based its approval on a 10-year study of 2,502 patients at 119 clinical sites in the United States and Canada. Patients were treated and followed for at least one year. The National Institutes of Health helped to fund the study, which found that patients treated with RX Acculink had a similar combined rate of death, stroke, and heart attack (myocardial inf
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Echo Therapeutics Expands Into New Headquarters in Philadelphia
2. BAETA Corp. Expands Market Awareness Programs
3. Optimer Pharmaceuticals Expands Senior Management Team
4. MedPro Imaging Expands Operations With Opening of Dedicated Advanced Transducer Repair Facility
5. DC Electronics Expands Facilities to Increase Capacity
6. Millstone Medical Outsourcing Expands Sales, Marketing Capacity, Hires Two Professionals
7. Transgenomic, Inc. Expands SURVEYOR® Scan Product Line With BRAF and PIK3CA Mutation Detection Kits
8. New England Biolabs Expands its Distribution Network through Collaborations in India and the Netherlands
9. CarePoint Partners Expands Texas Presence and Opens Georgia Market With Acquisition of Premier Infusion
10. SIRO Clinpharm Expands Presence in Asia
11. Cadence, Inc. Expands Executive Team
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/30/2014)... July 30, 2014 Research and Markets has ... - Forecasts to 2019" report to their offering. ... estimated to grow at a lower CAGR in developed countries; however, ... as China , India , ... The growth of the hematology analyzers and reagents market ...
(Date:7/30/2014)...  Today the US Surgeon General issued the most stern ... sun burns stating they can lead directly to deadly melanoma ... , says that "skin cancer is a major public health ... to indoor and outdoor ultraviolet light is a major cause." ... Boca Raton, Florida , Marta I. ...
(Date:7/30/2014)... , July 30, 2014 /PRNewswire-iReach/ -- Transluminal ... -based medical device company, has announced today that ... velox CD™ Vascular Closure Device. Velox CD™ provides ... hemostasis following percutaneous femoral procedures. The single size ... ranging in size from 5F to 8F.  ...
Breaking Medicine Technology:Hematology Analyzers & Reagents Market - Forecasts to 2019 2Indoor and Outdoor Sun Tanning or Sun Burns Directly Linked to Deadly Melanoma Skin Cancer 2Transluminal Technologies receives CE Mark approval for velox CD(TM) vascular closure device 2
(Date:7/30/2014)... July 30, 2014 Shabaikai is an ... forests of the Pomo Indians located on the shores ... the river Shabaikai, meaning ‘crooked snake’. Clarkson takes the ... and the violence of prohibition and organized crime, providing ... River. Here, the most powerful men in the world ...
(Date:7/30/2014)... Antonio, TX (PRWEB) July 30, 2014 ... with Christus Spohn Health, recently announced the proposed naming ... TX: the Dr. Hector P. Garcia Family Health Center. ... state-of-the-art primary health care services, including comprehensive chronic disease ... It will also be a pioneering medical home model ...
(Date:7/30/2014)... July 30, 2014 Naomi Fried, ... the Board of Directors of the American Telemedicine ... the Association, which has a mission to promote ... through telecommunications and information technology. , “Both Naomi ... Association, possess extraordinary expertise and are well known ...
(Date:7/30/2014)... have identified a protein that could help doctors decide ... that makes radiotherapy more effective, according to a study* ... (BJC). , The team from The University of Manchester, ... whose bladder tumour had high levels of a protein, ... carbogen oxygen mixed with carbon dioxide gas ...
(Date:7/30/2014)... Rhode Island Hospital researchers have found that a ... reduce depression and other symptoms in informal caregivers, ... dementia. The study is published online in advance ... Dementia . , "Those caring for people with ... often under a great deal of pressure," said ...
Breaking Medicine News(10 mins):Health News:Bill E. Clarkson Releases Debut Fact-Based Novel, Shabaikai 2Health News:Dr. Hector P Garcia Memorial Foundation Supports New Health Care Facility 2Health News:American Telemedicine Association Welcomes Two New Members to the Board of Directors 2Health News:Scientists pinpoint bladder cancer patients who could benefit from 'tumor-softening' treatment 2Health News:Study: Telephone support program beneficial for caregivers of those with dementia 2
... A paper by Indiana University-Purdue University Indianapolis ... to improve identification of breast cancer tissue by ... scientific paper in the "bioinformatics and biomedical applications ... The best scientific paper award ...
... "fused" with a groupa bond even stronger than group identificationwill ... outsiders, conclude researchers in a new study published in ... Science. This intense bond to a group may help explain ... B. Swann, Jr., of the University of Texas, came up ...
... and adolescents have become fatter over the last ... Bloomberg School of Public Health and National Institute ... across socio-demographic groups over time and found U.S. ... such as body mass index (BMI), waist circumference ...
... and women in the Troms Study in northern Norway has reported ... cognitive tests. The subjects (average age 58 and free of ... with a range of cognitive function tests. Among women, there was ... consumed wine at least 4 or more times over two ...
... By Steven Reinberg HealthDay Reporter , TUESDAY, Aug. ... of imaging to guide the needle now make up the majority ... the use of these minimally invasive biopsies increased from 59 percent ... trend which is likely to continue, one expert noted. A biopsy ...
... (CLASS) Act a largely overlooked component of the 2010 ... to transform long-term care financing in the United States from ... issue of Public Policy & Aging Report ... SCAN Foundation , this installment of PPAR features ...
Cached Medicine News:Health News:People with 'fused' identities are willing to die for their social group 2Health News:Overweight American children and adolescents becoming fatter 2Health News:Moderate drinking, especially wine, associated with better cognitive function 2Health News:Less Invasive Biopsies Gain Favor 2Health News:CLASS Act analysis reveals America's long-term care future 2
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
Medicine Products: