The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device, 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.
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 iwth 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.