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:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Austin residents ... the American College of Mohs Surgery and to Dr. Russell Peckham for medical and ... highly effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed ...
(Date:6/25/2016)... , ... June 25, 2016 , ... As a lifelong ... Cum Laude and his M.D from the David Geffen School of Medicine at UCLA. ... to Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... HOUSTON , June 23, 2016  MedSource ... platform as its e-clinical software solution of choice.  ... the best possible value to their clients by ... nowEDC.  The preferred relationship establishes nowEDC as the ... pricing for MedSource,s full-service clients.  "nowEDC has long ...
(Date:6/23/2016)... -- In a startling report released today, National Safety Council ... comprehensive, proven plan to eliminate prescription opioid overdoses. Prescription ... are tackling the worst drug crisis in recorded U.S. history, assigned ... Kentucky , New Mexico , ... 28 failing states, three – Michigan , ...
(Date:6/23/2016)... , June 23, 2016 Research ... Pharma News Issue 52" report to their offering. ... in influenza treatment creates a favourable commercial environment for MedImmune ... growing patient base that will serve to drive considerable growth ... vaccine would serve to cap sales considerably, but development is ...
Breaking Medicine Technology: