|
|
Article: AGA wins added clearance for common heart defect treatment.
- Article from:
- Medical Device Daily
- Article date:
- April 11, 2002
CopyrightCOPYRIGHT 2002 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
|
AGA wins added clearance for common heart defect treatment
By HOLLAND JOHNSON
Medical Device Daily Senior Staff Writer
AGA Medical (Golden Valley, Minnesota), one of the companies pioneering development of transcatheter technologies for the minimally invasive treatment of congenital heart defects, reported on Wednesday that the FDA has granted a Humanitarian Device Exemption (HDE) for use of its Amplatzer Patent Foramen Ovale Occluder for closing patent foramen ovales (PFOs). PFOs are gaps in the overlapping sections of the septum, the dividing wall of the hearts upper chambers.
Late last year, AGA won clearances for use of the ...