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:12/19/2014)... IRVINE, Calif. , Dec. 19, 2014 /PRNewswire/ ... today that Siddhartha Kadia, Ph.D. has joined the ... and Chief Executive Officer and a director of ... high-precision laboratory testing, evaluation and analytical services to ... Prior to joining Evans Analytical Group, ...
(Date:12/19/2014)... CHAPEL HILL, N.C. , Dec. 19, 2014 ... how to optimize a product,s web presence to ... critical. Brand websites, in particular, must meet the ... in regulations and culture. According ... LLC, more than half of the participating companies ...
(Date:12/19/2014)... Somewhere between dropping five pounds and cooking ... Audicus , a next-generation hearing aids company, will ... Hearing loss is the third most common ... is often unaddressed. Forty-eight million Americans have hearing loss, ... mainly due to price. Hearing aids traditionally cost $7,000 ...
Breaking Medicine Technology:Siddhartha Kadia, Ph.D. Joins Board of Directors of Newport Corporation 2Building a Best-in-Class Pharma Global Brand Website 2Audicus Will Help People Resolve to Hear Better in 2015 2
... HeartWare International, Inc. (NASDAQ: HTWR - ... circulatory support technologies that are revolutionizing the treatment of ... Assist System will be the subject of presentations at ... 31st Annual Meeting and Scientific Sessions, April 13-16 in ...
... announces that a new market research report is available ... Devices Market Outlook to 2017 ... Outlook to 2017 Summary ... Outlook to 2017" provides key market data on the ...
Cached Medicine Technology:HeartWare Announces Presentations at The International Society of Heart and Lung Transplantation Annual Meeting 2HeartWare Announces Presentations at The International Society of Heart and Lung Transplantation Annual Meeting 3HeartWare Announces Presentations at The International Society of Heart and Lung Transplantation Annual Meeting 4Reportlinker Adds North America Neurology Devices Market Outlook to 2017 2Reportlinker Adds North America Neurology Devices Market Outlook to 2017 3Reportlinker Adds North America Neurology Devices Market Outlook to 2017 4Reportlinker Adds North America Neurology Devices Market Outlook to 2017 5Reportlinker Adds North America Neurology Devices Market Outlook to 2017 6Reportlinker Adds North America Neurology Devices Market Outlook to 2017 7Reportlinker Adds North America Neurology Devices Market Outlook to 2017 8Reportlinker Adds North America Neurology Devices Market Outlook to 2017 9Reportlinker Adds North America Neurology Devices Market Outlook to 2017 10Reportlinker Adds North America Neurology Devices Market Outlook to 2017 11Reportlinker Adds North America Neurology Devices Market Outlook to 2017 12Reportlinker Adds North America Neurology Devices Market Outlook to 2017 13Reportlinker Adds North America Neurology Devices Market Outlook to 2017 14
(Date:12/22/2014)... NY (PRWEB) December 22, 2014 ... stronger than ever, having invested more than $5 ... service members, veterans and their families. , This ... nearly a dozen nonprofits, helping with: veteran entrepreneurship; ... scholarships; and life-coaches for severely injured veterans. , ...
(Date:12/22/2014)... recognition of Veteran’s Day, Discount Labels contributed a portion ... that provides services to veterans and their families, free ... hundred acres in the hills of Southern Indiana, the ... hiking, horseback riding, 4-wheeling, skeet shooting, and much more. ... U.S. Service men and women, police officers, fire fighters ...
(Date:12/22/2014)... 22, 2014 TheHardwareCity.com now stocks MagnoGrip ... many useful features. Customers of the large online tool ... new gloves delivered to their home or workplace with ... tools that incorporate heavy duty magnets, which make work ... workers to store metal parts on the back of ...
(Date:12/22/2014)... Ill. (PRWEB) December 21, 2014 ... recommendations for chest computed tomography (CT) to evaluate ... relevant findings, including cancer, according to a new ... , Researchers said the findings show that radiologist ... represent valuable contributions to patient care. , RAIs, ...
(Date:12/21/2014)... Recently, BambooFlooringChina.com, a famous bamboo lumber ... flooring collection , and launched a bamboo flooring promotion ... valid until Jan. 30, 2015. , According to the ... hardest bamboo flooring available today; it has a highly ... teak hardwoods. Strand woven bamboo is made by a ...
Breaking Medicine News(10 mins):Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 2Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 3Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 4Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 5Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 6Health News:Bob Woodruff Foundation Poised to Reach More Vets Thanks to Banner Year 7Health News:Discount Labels Donates Portion of November Sales to Hero Reward Program 2Health News:MagnoGrip Pro Utility Magnetic Gloves on Sale at TheHardwareCity.com 2Health News:RSNA: Radiologist Recommendations for Chest CT Have High Clinical Yield 2Health News:RSNA: Radiologist Recommendations for Chest CT Have High Clinical Yield 3Health News:BambooFlooringChina.com Announced Its Durable Strand Woven Bamboo Flooring Collection 2
... Deanne Williams, RN, CNM, MS, FACNM has focused her 30-year ... care with a particular focus on expanding access to nurse-midwifery ... and well-being of others, and to the nursing community, Williams ... University of Utah College of Nursing. She will be recognized ...
... ... has announced the appointment of Melissa Byington, vice president, CompHealth physician staffing group, to ... ... (NALTO) has announced the appointment of Melissa Byington, vice president, CompHealth physician staffing group, ...
... Process speeds formation of jaw bone, researchers say , ... healing and bone formation after tooth extraction, a new ... result in excessive jaw bone loss that may delay ... reconstructive surgery, or be impossible to repair, according to ...
... 3-year, retrospective study by cardiologists from the Minneapolis ... determined that 28.8% of patients with significant coronary ... revascularization had a higher mortality rate than patients ... in the May issue of Catheterization and ...
... ... appearance of jowls – those fleshy, droopy folds at the jaw line that ... most important part of a facelifting procedure. The issue will be debated ... Plastic Surgery (ASAPS), being held at the Gaylord National Hotel and Convention Center ...
... Streptococcus (GBS) are an under-recognised cause of urinary ... as a cause of infection in pregnant women with ... infants often with devastating consequences. Microbiologist Dr Glen ... Research, said pathogenic strains of GBS have been shown ...
Cached Medicine News:Health News:Nurse midwifery leader 2010 recipient of U. College of Nursing Distinguished Alumni Award 2Health News:Locum Tenens Organization Names CompHealth Executive to Board of Directors 2Health News:After Teeth Are Pulled, Platelet-Rich Plasma May Speed Healing 2Health News:Complete revascularization improves outcomes for CAD patients 2Health News:Facial Rejuvenation and the Jowl: How Far Should We Go? 2Health News:Facial Rejuvenation and the Jowl: How Far Should We Go? 3Health News:Facial Rejuvenation and the Jowl: How Far Should We Go? 4Health News:Strep steps up in urinary tract infections 2
... a mid range space saver specular microscope. It ... of the corneal endothelium automatically. It also has ... the central area. The image of the cells ... supplied with the system., This model is exactly ...
... The JSZ Orthokeratology (oprifocon ... gas permeable contact lenses used ... temporarily corrects nearsightedness (myopia). The ... and removes them in the ...
... rigid gas permeable contact lenses used for ... corrects nearsightedness (myopia). The patient wears the ... upon wakening. During the day, nearsightedness is ... and Quadra RG contact lenses apply slight ...
... Are You Aware of the High Prevalence ... Cardiovascular Disease Patient Population?, , As Prevalent ... Sleep Apnea (OSA), the most common form ... people in the United States. Only ...
Medicine Products: