The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper.
In a closer vote, the same panel ruled 11-5 that the device’s benefits outweigh its risks and 9-7 that it is effective for its intended use.
“We’ve searched long and hard for new ways to prevent the risk of recurrent strokes in patients with a PFO, as these strokes can often be debilitating. For these patients, closure with the Amplatzer PFO Occluder is an important treatment option, and today is an important step toward approval of this technology in the United States,” chief medical officer Dr. Mark Carlson said, according to the Star Tribune.
Back in October 2012, the Amplatzer PFO device failed to meet the primary endpoint in a 980-patient clinical trial comparing it with drug therapy in patients with recurrent cryptogenic stroke and PFO. The Respect study showed that 9 patients in the Amplatzer arm suffered non-fatal strokes, compared with 16 in the drug treatment cohort, a non-statistically significant reduction of 50.8%.
St. Jude said at the time that a quirk in the study’s design meant that 3 of the Amplatzer patients were never actually implanted with the device. Excluding those patients, and patients in the drug treatment cohort who dropped drug therapy, and the risk of stroke in the Amplatzer arm fell to 63%. And later analyses showed a “magnification” of benefits when 24 non-implanted patients were taken out of the Amplatzer arm and fewer and smaller strokes than patients who received drug therapy alone.
Little Canada, Minn.-based St. Jude bought its Amplatzer technology, along with AGA Medical, for $1.03 billion in 2010.