AGA Receives Approval For AMPLATZER Muscular Ventricular Septal Defect Occluder
AMPLATZER Muscular Ventricular Septal Defect Occluder
AGA Medical Corporation has received FDA approval to market the AMPLATZER Muscular Ventricular Septal (VSD) Occluder.
The AMPLATZER Muscular VSD Occluder is intended in patients for transcatheter closure of a complex ventricular septal defect of a sufficient size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure). The patient must also be considered at high risk for surgical closure based either on the anatomy of the defect or the patient's overall medical condition. VSDs typically occur in infants and are the most common type of congenital heart defect.
"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 AMPLATZER Duct Occluder, provide U.S. cardiologists with the most comprehensive set of tools from any single company to treat structural heart disease."
The AMPLATZER Muscular VSD Occluder consists of two discs made of self expanding nitinol. The device is implanted via a catheter, a procedure that is a less-invasive alternative to open heart surgery and results in shorter recovery time. To increase the closing ability, the discs are filled with polyester fabric that is secured to the disc. The Muscular VSD Occluder uses the unique AMPLATZER interface between the device and delivery cable. This screw attachment permits the device to be retrieved and repositioned prior to release from the cable.
As part of the approval conditions, AGA has agreed to conduct a five-year post approval study to evaluate long-term safety and effectiveness. In addition, AGA will enroll at least 100 patients in a prospective registry study that will include an evaluation of immediate post-procedural technical success, occurrence of major complications acutely and over designated time intervals, as well as longer term success in closing the shunt associated with the VSD.