Navigation Links
AGA Medical Receives Japanese Approval for AMPLATZER(R) Duct Occluder
Date:1/7/2009

MINNEAPOLIS, Jan. 7 /PRNewswire/ -- AGA Medical Corporation ("AGA Medical") announced today that it received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its AMPLATZER(R) Duct Occluder (ADO). The ADO is a percutaneous, transcatheter occlusion device used for the non-surgical closure of patent ductus arteriosus (PDA), a common type of congenital heart defect that occurs when a blood vessel known as the ductus arteriosus fails to close after birth, as it normally should.

"We are very pleased to achieve this regulatory and commercial milestone in Japan," said John Barr, President and CEO of AGA Medical. "Our exclusive distribution partner, Japan Lifeline Co., Ltd., will immediately apply for reimbursement and intends to launch the product to the market in the first half of 2009 following receipt of reimbursement."

The ADO is the second AGA Medical device to receive approval in Japan. The company's AMPLATZER(R) Septal Occluder (ASO) was previously approved in 2005 and launched in May 2006. All medical devices in Japan must receive reimbursement approval prior to marketing of the product.

The ADO is intended for the closure of PDAs larger than 4 millimeters, which represent approximately 30 percent of total PDA defects. Uniquely shaped to achieve consistent, effective closure, the device is made of self-expanding nitinol mesh and is designed to be introduced in a minimally invasive fashion through a catheter. The ADO employs a retention "skirt," which allows the device to be positioned properly and remain in place at the entrance to the duct. Additionally, the device leverages the proven fully retrievable and repositionable screw technology platform used in all AGA Medical devices, which provides physicians with simple, controlled and precise delivery, ensuring a customized fit for each individual patient's anatomic structure.

The AMPLATZER Duct Occluder was granted Conformite Europeenne (CE) Mark in Europe in February 1998 and U.S. Food and Drug Administration (FDA) approval in May 2003. AGA Medical's second generation AMPLATZER Duct Occluder - ADO II - has been granted CE Mark approval in Europe and can be delivered through even smaller catheters and is appropriate for both smaller ducts and ducts with different geometries. AGA Medical has a clinical trial underway to support approval for the ADO II in the United States.

About Patent Ductus Arteriosus

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. PDA can also be asymptomatic. Large openings can lead to heart failure and death.

About AGA Medical

AGA Medical, 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, patent ductus arteriosis, 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©2009 PR Newswire.
All rights reserved

Related medicine news :

1. MSU engineering team designs innovative medical device
2. ATS Medical to Present at the 2007 Thomas Weisel Partners Healthcare Conference
3. Providence St. Joseph Medical Center, Caregivers Reach Agreement on a Union Contract
4. Owner and Operator of Florida Durable Medical Equipment Company Convicted of Medicare Fraud
5. Father and Daughter From Tanzania Receive Their First Medical Examination in Newport Beach
6. Doctors and medical ethicist discuss whether doctors should participate in capital punishment
7. Preparation for Natural Disasters Critical for People With Diabetes, Chronic Medical Conditions
8. Doctors and Medical Ethicist Discuss Whether Doctors Should Participate in Capital Punishment
9. Symmetry Medical Completes Acquisition Of Specialty Surgical Instruments
10. Milestone Scientific Announces Successful Completion of its Collaboration Agreement With Carticept Medical
11. FDA Seeks to Regulate Complementary and Alternative Medicine; Products Such as Vegetable Juice Could Be Restricted for Medical Use
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/27/2017)... ATLANTA, Ga. (PRWEB) , ... July 27, 2017 , ... ... Man native Sam Brand to the men’s pro squad as a stagiaire for the ... to make his professional debut on July 31st at the Tour of Utah. , ...
(Date:7/26/2017)... ... ... Capillus, LLC has announced the redesign of their FDA-cleared low-level laser (light) ... a more comfortable, adaptable fit and is available for purchase immediately. , Carlos ... therapy caps intended to improve both user experience and hair regrowth. , “Our ...
(Date:7/26/2017)... Ca (PRWEB) , ... July 26, 2017 , ... A ... lyophilization processes. Inconsistent results freeze drying samples and a lengthy freeze dry cycle are ... webinar will discuss freeze drying techniques, as well as new accessories and advancements in ...
(Date:7/26/2017)... ... , ... It's time to sign up for the new One-A-Month Essential Oil Club ... founder of Sublime Naturals and author of numerous books on essential oils. , ... the 5th. , Two items are included in the December mailing. , ...
(Date:7/26/2017)... , ... July 26, 2017 , ... ... and cats has opened in Jupiter. The state of the art center ... class leading treatments with a goal of providing heart patients longer lives. , ...
Breaking Medicine News(10 mins):
(Date:7/26/2017)... LOVELAND, Colo. , July 26, 2017 ... Tristan Guttridge and the Bimini SharkLab to custom design the ... diagnostic images of sharks in their native habitat. In ... for Discovery Channel,s Shark Week, Dr. Guttridge approached ... to take pregnancy diagnosis directly to hammerhead sharks underwater. ...
(Date:7/26/2017)... July 26, 2017 The Galien Foundation ... USA Award Nominees. Counted among the ... Award recognizes outstanding biomedical and technology product achievement that improves ... To qualify, each candidate must be U.S. Food and Drug ... and demonstrate tremendous potential to impact human health. Sales data ...
(Date:7/24/2017)... , July 24, 2017 IBM (NYSE: IBM ... Magic Quadrant for Solid-State Arrays (SSA) for the fourth year ... According to Gartner, "Vendors in the Leaders quadrant have ... of Vision. A vendor in the Leaders quadrant has the ... drive the acceptance of new technologies. These vendors demonstrate a ...
Breaking Medicine Technology: