Healthcare Industry News: AMPLATZER
News Release - February 11, 2008
AGA Medical Corporation Receives European CE Mark Approval for the AMPLATZER(R) Duct Occluder IIMINNEAPOLIS, Feb. 11 (HSMN NewsFeed) -- AGA Medical Corporation ("AGA") announced today it received European CE Mark approval for the AMPLATZER® 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 The ADO II is designed with a screw mechanism for attachment to the deployment cable that allows the device to be withdrawn and repositioned, if necessary, prior to release from the cable.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 www.AMPLATZER.com.
Source: AGA Medical
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