Navigation Links
AGA Medical Corporation Receives European CE Mark Approval for the AMPLATZER(R) Duct Occluder II
Date:2/11/2008

MINNEAPOLIS, Feb. 11 /PRNewswire/ -- AGA Medical Corporation ("AGA") announced today it received European CE Mark approval for the AMPLATZER(R) Duct Occluder II ("ADO II"). AGA also announced the immediate availability and launch of the device in Europe. The ADO II expands the AGA family of occlusion devices designed to occlude or close a patent ductus arteriosus ("PDA"), a type of congenital heart defect that occurs when a blood vessel called the ductus arteriosus fails to close after birth, as it normally should.

"We believe the new ADO II represents a development milestone for AGA Medical and demonstrates the success of our product development programs," said Franck Gougeon, President and CEO of AGA. "It is our first approved occlusion device designed to treat structural heart defects that does not include fabric to assist in rapid occlusion. This expands the type of ducts that can be closed by our family of PDA devices."

The ADO II is a self-expanding nitinol mesh device and is designed to be introduced in a minimally invasive fashion through a catheter. The device has two retention disks positioned on either side of the duct and connected by a waist. The ADO II is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.

The device treats a PDA. The ductus arteriosus is an open channel in every fetus that allows blood to bypass the lungs, which are not used until the baby takes its first breath after birth. Shortly after the baby's first breath, the ductus arteriosus should close permanently. If it does not close, it is known as a PDA. This condition can cause symptoms such as fatigue, difficulty or rapid breathing, failure to grow normally, or chronic respiratory infections such as colds and pneumonia, or endocarditis.

"The ADO II greatly improves treatment options for babies and young children because it can be used with very small diameter catheters," said Mr. Gougeon.

The original Amplatzer Duct Occluder received the CE Mark in 1998 and was approved by the U.S. Food and Drug Administration ("FDA") in 2003. It is currently under review by Japanese regulatory authorities. AGA shipped more than 51,000 Amplatzer Duct Occluders in the United States, Europe and other international markets as of December 31, 2007. AGA has applied with the FDA to conduct a clinical trial in the U.S. to support approval for the ADO II.

ABOUT AGA MEDICAL: AGA Medical Corporation, based in Plymouth, Minnesota (just outside Minneapolis), is a leader in developing interventional devices to treat structural heart defects. As a result of the many contributions and creative genius of Dr. Kurt Amplatz, AGA develops and commercializes a series of devices that have revolutionized the treatment of the most common congenital "holes in the heart" such as atrial septal and patent foramen ovale defects. The company is expanding into new areas such as the minimally invasive repair of vascular abnormalities. More than 770 articles have been published in medical publications that support the benefits of AGA 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 with more than 278,000 devices shipped to date. For more information visit http://www.amplatzer.com.

MEDIA CONTACT:

Jake Sargent

Brunswick Group LLC

202.393.7337

jsargent@brunswickgroup.com


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

Related biology technology :

1. AGA Medical Corporation Responds to Occlutech Statement on the Status of the Ongoing Patent Litigation in Europe
2. Alynx, Co. Completes Merger With Medical Device Company MiMedx, Inc.
3. BioMS Medical to present at BIO CEO & Investor Conference
4. Tutogen Medical, Inc. Reports First Quarter Fiscal 2008 Financial Results
5. Linc Facility Services Acquires Morse Medical
6. Perrigo Company to Present at the Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
7. Covance to Present at Merrill Lynch Global Pharmaceutical, Biotechnology and Medical Device Conference
8. Blue Cross and Blue Shield of Texas Launches an Integrated Medical-Dental Health Program
9. Tryton Medical Receives CE Mark Approval for its Side-Branch Stent
10. Rochester Medical Reports 31% Increase in Branded Sales Resulting in 9% Overall Sales Growth for the First Quarter
11. Medical University of South Carolina Opens State-of-the-Art Facility
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 /PRNewswire/ - FACIT has announced the creation ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" or "the ... a portfolio of first-in-class WDR5 inhibitors for the ... WDR5 represent an exciting class of therapies, possessing ... for cancer patients. Substantial advances have been achieved ...
(Date:6/23/2016)... , June 23, 2016  The Prostate Cancer Foundation (PCF) ... precise treatments and faster cures for prostate cancer. Members of the Class of ... 15 countries. Read More About the Class of 2016 ... ... ...
(Date:6/23/2016)... ... , ... STACS DNA Inc., the sample tracking software company, today announced that ... joined STACS DNA as a Field Application Specialist. , “I am thrilled that ... of STACS DNA. “In further expanding our capacity as a scientific integrator, Hays brings ...
(Date:6/23/2016)... LONDON , June 23, 2016 ... & Hematology Review, 2016;12(1):22-8 http://doi.org/10.17925/OHR.2016.12.01.22 ... Review , the peer-reviewed journal from touchONCOLOGY, ... the escalating cost of cancer care is placing ... a result of expensive biologic therapies. With the ...
Breaking Biology Technology:
(Date:4/28/2016)... FRANCISCO and BANGALORE, India , ... of EdgeVerve Systems, a product subsidiary of Infosys (NYSE: ... provider, today announced a global partnership that will ... way to use mobile banking and payment services. ... is a key innovation area for financial services, but it ...
(Date:4/15/2016)... April 15, 2016  A new partnership announced ... accurate underwriting decisions in a fraction of the ... priced and high-value life insurance policies to consumers ... With Force Diagnostics, rapid testing (A1C, Cotinine ... readings (blood pressure, weight, pulse, BMI, and activity ...
(Date:3/31/2016)... 2016  Genomics firm Nabsys has completed a financial ... Bready , M.D., who returned to the company in ... leadership team, including Chief Technology Officer, John Oliver ... Nurnberg and Vice President of Software and Informatics, ... Dr. Bready served as CEO of Nabsys from ...
Breaking Biology News(10 mins):