RESPECT Trial designed to investigate the potential connection between a congenital heart defect and cryptogenic stroke
AGA Medical Corporation and Tedy Bruschi, a recently retired professional football player, today launched a Web-based stroke education and awareness video, emphasizing the importance of gathering scientific data through clinical trials. In the video, Bruschi - who suffered a stroke in 2005, subsequently recovered and returned to his career - describes the AGA Medical-sponsored RESPECT clinical trial. The RESPECT trial is investigating whether closure of the Patent Foramen Ovale (PFO), a congenital heart defect, using an AGA Medical device is safe and effective compared to current standard of care treatment in the prevention of a cryptogenic stroke. A cryptogenic stroke is one for which the origin or cause of stroke is unknown.
“For many patients, the cause of their stroke will never be known, and they live in fear of suffering another stroke,” said Bruschi. AGA Medical and Bruschi previously issued six videos highlighting the athlete’s experiences as a stroke victim, survivor and prevention champion. Bruschi continued, “The RESPECT trial is designed to determine if an open PFO is a potential cause of stroke and can be treated with a PFO closure device. Participants in this clinical trial will help us better understand stroke and advance potentially life-saving therapies.”
AGA Medical announced its partnership with Bruschi in December 2008, launching a series of videos where Bruschi describes the warning signs of stroke and discusses his personal stroke experience. This latest video raises awareness about the RESPECT clinical trial and complements AGA Medical’s comprehensive stroke education, awareness and prevention campaign. All videos are available at www.amplatzer.com/strokeawareness.
“We appreciate Tedy’s personal involvement in our efforts to raise awareness about stroke prevention,” said John Barr, chief executive officer of AGA Medical. “Tedy’s story helps people understand the magnitude of stroke, from the number of people it affects to what we can do in the area of prevention.” On the RESPECT trial, Barr said, “At AGA Medical, we launched the RESPECT trial to better understand the relationship between PFO and cryptogenic stroke.”
Stroke, defined as a sudden injury to the brain caused by a blood vessel bursting or becoming blocked, is the nation’s No. 3 cause of death behind heart disease and cancer. The American Heart Association reports that each year about 700,000 Americans suffer from a stroke. One-third of stroke victims are under 65, and even children can suffer a stroke.
RESPECT Clinical Trial Underway
AGA Medical is currently conducting the RESPECT trial, a multicenter, randomized U.S. clinical study to investigate whether closure of a congenital heart defect using an AGA Medical device is superior to current standard of care treatment in the prevention of a particular type of stroke. Evidence indicates there may be a connection between Patent Foramen Ovale (PFO) and cryptogenic stroke. The AMPLATZER® PFO Occluder is not approved for use in the U.S. outside of ongoing clinical trials.
PFO is one potential suspected cause of cryptogenic stroke. The foramen ovale is a flap or tunnel-shaped hole in the atrial septum, the wall that divides the upper two chambers of the heart, that forms during fetal development to allow blood to travel through the heart without going to the lungs. This small flap-like opening normally closes shortly after birth as the pressure from the baby’s heart pushes the flap to the septal wall. A PFO results if this opening does not completely close shortly after birth.
For more information on the clinical trial and the warning signs of stroke, visit www.amplatzer.com/us/Respect/amplatzer.com.
About Tedy Bruschi
Coming off the success of winning his third league championship and playing in the annual league all-star game in February 2005, Tedy unexpectedly experienced a stroke. On the advice of his physician, a device from AGA Medical was prescribed and implanted as part of Tedy’s treatment. After several months of extensive rehabilitation and recovery, Tedy was medically cleared to resume playing football less than a year later. Today, Tedy dedicates a considerable part of his personal time toward raising stroke awareness and funds for stroke research.
To learn more about Tedy and the warning signs of stroke, visit www.amplatzer.com/strokeawareness.
About AGA Medical Corporation
AGA Medical Corporation, based in Plymouth, Minn., is a leader in developing interventional devices for the minimally invasive treatment of structural heart defects and peripheral vascular disorders. Founded in 1995 by Dr. Kurt Amplatz, a former University of Minnesota professor and researcher, AGA Medical’s range of AMPLATZER® products help improve patient outcomes, reduce length of hospital stay and accelerate patient recovery times. AMPLATZER products significantly advanced the treatment of the most common congenital “holes in the heart,” such as atrial septal defects, patent foramen ovale and ventricular septal defects. More than 1,100 articles supporting the benefits of AMPLATZER products have been published in medical literature. AGA Medical markets AMPLATZER products in 101 countries worldwide. For more information, visit www.amplatzer.com.
AGA Medical Corporation
Nick Banovetz, 612-455-1705
Padilla Speer Beardsley