Government and Regulations
Standard vs Intensive Emergency Stroke Treatment
Study results find little to no difference in blood pressure levels based on severity of stroke treatment.
The FDA has approved the Amplatzer PFO Occluder (St. Jude Medical Inc), a nonsurgical method to close a patent foramen ovale (PFO) in patients who have had a stroke.
About 25% to 30% of patients have a PFO, which typically does not require treatment. However, patients with an unidentified cause of stroke and a PFO may have a higher risk of a second stroke.
The Amplatzer PFO Occluder is inserted through a catheter placed in a leg vein and advanced to the heart. It is then implanted close to the hole in the heart between the right and left atria.
Related: Standard vs Intensive Emergency Stroke Treatment
Researchers evaluated 499 patients treated with the Amplatzer PFO Occluder plus blood-thinning medication, and 481 patients treated with blood-thinners alone. The rate of new strokes in both groups was very low, but the group treated with the device had a 50% lower rate.
The device had been on the market more than 10 years ago with a humanitarian device exemption. It was withdrawn when the FDA concluded that the target population was greater than 4,000 patients and the device no longer qualified for the exemption. No FDA-approved heart occluder devices with this indication have been on the market in the years since. Now, in approving the device—again—the FDA says it has demonstrated a “reasonable assurance of safety and effectiveness.”
Related: Development of a Multidisciplinary Stroke Program
The FDA advises that patients should be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke, to ensure that PFO closure is likely to help reduce the risk of recurrent stroke.