St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke.
Approximately 25-30% of Americans have a PFO, according to the FDA, which typically causes no health problems and does not require treatment. While the cause of most strokes can generally be identified, some patients experience strokes which cannot be medically identified, known as cryptogenic stroke.
A small percentage of cryptogenic strokes are believed to be caused by PFOs, which provide a path for a blood clot to travel to the brain. The FDA said that patients with a cryptogenic stroke and a PFO may be at an increased risk for a second stroke.
“The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO. But as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of a recurrent stroke,” FDA CDRH cardiovascular devices division director Dr. Bram Zuckerman said in an FDA release.
The Amplatzer PFO occluder is designed to be delivered via catheter to close the hole in the heart between the top right chamber and top left chamber. The approval of the device was based on data from studies of the device which “demonstrated a reasonable assurance of safety and effectiveness,” the FDA wrote.
The federal watchdog warned that the device should not be used in patients with a heart valve infection or other untreated infections, heart tumors or blood clots at the implant site.
The device is also contraindicated for patients with abnormal connections between heart chambers or patients in whom the “cardiovascular anatomy or blood clots would interfere with the ability to move the catheter used to deliver the device to the heart.”
Earlier this month, St. Jude said it launched a pediatric clinical trial of a version of its Amplatzer cardiac implant for treating a congenital heart defect.
The 50-patient ADO II AS study is designed to enroll 2 patient cohorts: at least 15 patients weighing 4.4 lbs. (2kg) or less and at least 25 patients weighing more than that.
Little Canada, Minn.-based St. Jude said the ADO II AS device is designed to treat a common congenital heart defect called patent ductus arteriosus via pulmonary or aortic artery approach. The company said it plans to use data from the study to back a pre-market approval application with the FDA (the device is already approved in more than 50 other countries, St. Jude said).
