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AGA Medical Corporation Receives Approval for the AMPLATZER Muscular Ventricular Septal Defect Occluder

Tuesday, September 11, 2007 General News
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MINNEAPOLIS, Sept. 10 AGA Medical Corporation ("AGA")announced today that it has received U.S. Food and Drug Administration (FDA)approval to market the AMPLATZER Muscular Ventricular Septal (VSD) Occluder.
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The AMPLATZER Muscular VSD Occluder is intended in patients fortranscatheter closure of a complex ventricular septal defect of a sufficientsize to warrant closure (large volume left to right shunt, pulmonaryhypertension and/or clinical symptoms of congestive heart failure). Thepatient must also be considered at high risk for surgical closure based eitheron the anatomy of the defect or the patient's overall medical condition. VSDstypically occur in infants and are the most common type of congenital heartdefect.
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"We are pleased to make the Muscular VSD Occluder available for our U.S.physician customers," said Franck Gougeon, President and CEO of AGA. "The VSD,along with the previously approved AMPLATZER Septal Occluder and AMPLATZERDuct Occluder, provide U.S. cardiologists with the most comprehensive set oftools from any single company to treat structural heart disease."

The AMPLATZER Muscular VSD Occluder consists of two discs made of selfexpanding nitinol. The device is implanted via a catheter, a procedure that isa less-invasive alternative to open heart surgery and results in shorterrecovery time. To increase the closing ability, the discs are filled withpolyester fabric that is secured to the disc. The Muscular VSD Occluder usesthe unique AMPLATZER interface between the device and delivery cable. Thisscrew attachment permits the device to be retrieved and repositioned prior torelease from the cable.

As part of the approval conditions, AGA has agreed to conduct a five-yearpost approval study to evaluate long-term safety and effectiveness. Inaddition, AGA will enroll at least 100 patients in a prospective registrystudy that will include an evaluation of immediate post-procedural technicalsuccess, occurrence of major complications acutely and over designated timeintervals, as well as longer term success in closing the shunt associated withthe VSD.

ABOUT AGA MEDICAL: AGA Medical Corporation, based in Plymouth, Minnesota(just outside Minneapolis), is the leader in developing interventional devicesto treat structural heart defects. As a result of the many contributions andcreative genius of Dr. Kurt Amplatz, the company has developed andcommercialized a series of devices that have revolutionized the treatment ofthe most common congenital "holes in the heart," such as atrial septal andpatent foramen ovale defects. The company is expanding into new areas,including the minimally invasive repair of vascular abnormalities. Over 700articles have been published in peer reviewed medical publications thatsupport the benefits of AGA Medical devices, such as improved patientoutcomes, reduced length of stay and accelerated recovery times for thepatient. AGA Medical devices have received regulatory approval and aremarketed in over 90 countries with over 250,000 devices shipped to date. Formore information visit http://www.amplatzer.com.MEDIA CONTACT: Jake Sargent Brunswick Group LLC 202.393.7337 [email protected]

SOURCE AGA Medical Corporation
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