Navigation Links
AGA Medical Receives European CE Mark Approval for AMPLATZER(R) Cardiac Plug
Date:12/3/2008

MINNEAPOLIS, Dec. 3 /PRNewswire/ -- AGA Medical Corporation announced today that it received European CE Mark (Conformite Europeenne) approval for its AMPLATZER(R) Cardiac Plug (ACP). The ACP provides an innovative, minimally invasive solution for closing cardiac structures not involving the septal wall. One such intended use will be for the non-surgical occlusion of the left atrial appendage.

"The ACP is an important addition to the interventional tools we have for structural heart repair. The design and conformability of the device as well as its ease of deliverability will allow us to effectively occlude challenging anatomy such as the left atrial appendage," said Bernhard Meier, MD, FACC, FESC, professor and chairman of cardiology, University Hospital, Bern, Switzerland. "Scientific data suggests a strong link between atrial fibrillation and formation of thrombus in the left atrial appendage, which can increase the risk of stroke to 5 percent per year. Physicians have limited options to minimize stroke risk other than anticoagulants which are often associated with adverse side effects."

Made of flexible braided Nitinol mesh, the ACP is designed to provide occlusion with full cross-sectional coverage. The ACP self-orients to the cardiac wall, covering the hole of the structure to be occluded. It leverages the proven microscrew technology platform used in all AGA Medical devices to provide physicians with simple, controlled and precise delivery. This allows the ACP to be recaptured and repositioned if necessary, ensuring a customized delivery and fit for each patient's unique anatomic structure.

"Receiving CE Mark approval for the ACP is a significant milestone for AGA Medical," said John Barr, President and CEO, AGA Medical Corporation. "This device exemplifies our commitment to making structural heart devices that are clinically relevant, safe and easy to use. With approximately 5 percent of the population over the age of 65 diagnosed with atrial fibrillation, it is one of the most prevalent conditions in this age group. We believe a very large number of patients will benefit from the availability of the ACP."

AGA Medical will immediately begin marketing of the ACP in Europe and plans to support the broad adoption of left atrial appendage occlusion for atrial fibrillation. It will also introduce a physician clinical training program utilizing the latest medical simulation technology. The company has filed for an Investigational Device Exemption (IDE) with the U.S. Food and Drug Administration (FDA) for clearance to begin a clinical trial in the United States in the first half of 2009.

About AGA Medical Corporation

AGA Medical Corporation, based in Plymouth, Minnesota, is a leader in developing interventional devices for the minimally invasive treatment of cardiovascular defects and peripheral vascular disease. Founded in 1995 by Dr. Kurt Amplatz, a former professor and researcher at the University of Minnesota Department of Radiology, AGA Medical develops and commercializes devices for a range of structural heart repair and circulatory conditions. Several of these devices have been major innovations in the treatment of the most common congenital "holes in the heart", such as atrial septal defects and patent foramen ovales.

More than 700 articles have been published in medical literature that support the benefits of AGA Medical devices, including improved patient outcomes, reduced length of stay, and accelerated recovery times for the patient. AGA Medical devices have received regulatory approval and are marketed in 101 countries. For more information, visit http://www.amplatzer.com.


'/>"/>
SOURCE AGA Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. UCSF Medical Center Leads Nation in ER Heart Attack Care
2. Driving Consumer Engagement Is Focus of Address by Healthfitness Chief Medical Officer at Watson Wyatt Health Care Solutions Event
3. Medical-Billing.com to Revolutionize Electronic Medical Recordkeeping With National Patient Registry
4. Cantel Medical Corp. to Hold Conference Call to Discuss Results for Its First Quarter Ended October 31, 2008
5. New Report Recommends Strategies to Reduce Medical Resident Fatigue-Related Errors and Improve Training
6. Revised hours and workloads for medical residents needed to prevent
7. Consumers Uncertain About Their Medical Diagnosis & Treatment
8. Response Biomedical Corporation Announces Initiation of Respiratory Syncytial Virus Infection Clinical Trial
9. Levaquin is the Preferred Quinolone Among More Than Half of All General Medical-Surgical Hospitals in the United States
10. China Sky One Medical, Inc. Appoints Yu-bo Hao as CFO
11. The National Health Service and Attainia Move to Modernize Medical Capital Equipment Budgeting and Planning for the United Kingdom
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... ... February 23, 2017 , ... ... 2017 partnership with The Jensie Gran Fondo of Marin. For the second year ... with Thinksport’s broad-spectrum, mineral-based sunscreen. , “We are thrilled to provide our safe, ...
(Date:2/23/2017)... ... 23, 2017 , ... The Lymphoma Research Foundation (LRF) – ... serving the lymphoma community through a comprehensive series of education programs, outreach initiatives ... Miami Beach to host its Swirl: Miami Wine Tasting Event on March 28, ...
(Date:2/23/2017)... ... February 23, 2017 , ... Los Angeles-based weight loss surgeon Michael ... “Mama June: From Not to Hot,” which will begin airing on February 24, 2017. ... to millions from the 2012 reality television series, “Here Comes Honey Boo Boo.” The ...
(Date:2/23/2017)... ... February 23, 2017 , ... EBSCO ... the National Institute for Health and Care Excellence (NICE) framework. The ... National Health Service (NHS) to search, order and purchase medical and healthcare-related content ...
(Date:2/23/2017)... ... February 23, 2017 , ... Pink ... publication where generations converge and explore the world from different perspectives. By providing ... enables readers to gain understanding, increase empathy, and find greater happiness. , ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... , Feb. 23, 2017 Non-alcoholic ... on the various drugs being developed for ... all the drugs that are in various ... The pipeline focuses on novel pharmacologic drugs ... stem cell therapies, recombinant proteins and RNA-based ...
(Date:2/24/2017)... -- Xynomic Pharmaceuticals, Inc., an oncology drug research and ... exclusive worldwide rights to develop, manufacture and commercialize ... hematological and solid tumors. To date ... clinical trials of Abexinostat in US, EU and ... completed, demonstrating that Abexinostat is clinically active in ...
(Date:2/23/2017)... Research and Markets has announced the addition of the ... report to their offering. ... The latest research Autism Spectrum Disorder Drugs Price Analysis ... the global Autism Spectrum Disorder market. The research answers the ... drugs marketed for Autism Spectrum Disorder and their clinical attributes? How ...
Breaking Medicine Technology: