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 infarction) as those who underwent surgery.

An outside expert advisory panel convened by the FDA on Jan. 26, 2011, found the RX Acculink to be generally safe and effective for use in this new group of patients. But the panel emphasized the need for additional long-term follow-up information and the importance of the stent's use in conjunction with an embolic protection device to capture plaque and other debris that break away during the procedure, potentially causing a stroke.

As a condition of the approval, the manufacturer, Abbott Vascular, is required to conduct a post-approval study, which will follow new patients treated with RX Acculink for at least three years to confirm the results identified in the pre-market study. The post-approval study will also evaluate how patients age 80 years and older respond to treatment, whether treatment success is affected by the physician's experience with the product, and whether patients who show symptoms of having a clogged carotid artery experience a different outcome than those who don't show any symptoms prior to treatment. The study is consistent with recommendations made by the expert advisory panel.

Abbott Vascular, a subsidiary of Abbott Laboratories, is located in Santa Clara, Calif.

For more information:

FDA: Medical Devices

http://www.fda.gov/MedicalDevices/default.htm

FDA: Device Approvals and Clearances

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

NIH: Carotid Endarterectomy (Carotid artery surgery)

http://www.nhlbi.nih.gov/health/dci/Diseases/carend/carend_what.html

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


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

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:2/9/2016)... Feb. 9, 2016 This TforG report includes ... by the ICD-9 coding system in South ... procedure volumes, the report provides written and numerical analysis ... local markets. In addition, the latest reforms of the ... --> --> The report helps businesses ...
(Date:2/9/2016)... Feb. 9, 2016 The life of Dr. ... has been anything but ordinary.  Twists of fate, combined with ... II and the constraints of communist Czechoslovakia to ... would go on to make history by playing a key ... drugs in the world, Remicade.  Dr. Vilcek brings readers along ...
(Date:2/9/2016)... , Feb. 9, 2016 The new report " Global ... by Spearhead Acuity Business Research & Consulting group reveals that ... neonatal market with a share of 36.4% in 2014 that translated ... , the report also covers market analysis for Fetal and ... , Asia-Pacific , Latin America ...
Breaking Medicine Technology:
(Date:2/9/2016)... ... 09, 2016 , ... Cirracore Enterprise Cloud, today announced that ... the cloud. Cirracore provides a secure VMware® vCloud Air based cloud that ... Transformation Solutions (TSL Partners) provides a full range of services from planning, discovery, ...
(Date:2/9/2016)... ... February 09, 2016 , ... Establishment Labs, a global ... David Hung to the company´s Board of Directors. , “We are honored ... and an exceptional entrepreneur.” said Juan Jose Chacon Quiros, CEO of Establishment Labs. "David’s ...
(Date:2/9/2016)... ... February 09, 2016 , ... The ... Herberger’s and Younkers department stores, announced it has raised $176,000 to benefit the ... Holden Comprehensive Cancer Center at the University of Iowa, The Lynn Sage Cancer ...
(Date:2/9/2016)... ... February 09, 2016 , ... METTLER TOLEDO has published a ... a basic understanding of the techniques they use so they can more easily ... reduce waste and rework to create a leaner overall lab experience. , ...
(Date:2/9/2016)... ... February 09, 2016 , ... United Methodist ... Praise of Prevention,” an animated video designed to prevent the next ... of the video are being distributed throughout Togo, Liberia, Sierra Leone, Nigeria, Côte ...
Breaking Medicine News(10 mins):