Medical device giant St. Jude Medical (NYSE:STJ) is taking another swing at clinical trial data for its Amplatzer patent foramen ovale closure device, reporting that a narrower view of the patient population shows that Amplatzer does help reduce strokes.
Data from St. Jude’s RESPECT trial (Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment) suggest a "magnification" of benefits when considering only patients who were fitted with the device, rather than the entire "intention-to-treat" population.
In the newest analysis, presented during last month’s European Stroke Conference, researchers shifted 24 patients from the treatment arm to the control arm. Those patients had originally been placed in the Amplatzer device group, but never actually received the implant, Dr. Jeffrey Saver told Medscape.
The swap made a significant difference, Saver added. The new analysis suggests that the Amplatzer patients experienced a 70% reduction in stroke risk.
"When you do this type of analysis you are removing some of the noise that happens by chance, and if the treatment is working, the effect should be magnified," Saver told the news source. "These results provide further evidence that there is a genuine biologic effect."
St. Jude took a hit last year when the RESPECT trial failed to meet its clinical endpoints. The trial concluded that the Amplatzer heart implant failed to significantly reduce cryptogenic stroke compared with standard treatment with drugs, sending STJ shares sinking on Wall Street and putting fellow PFO closure devices makers on the defensive.
St. Jude has since made a few efforts to re-analyze the data, including during the International Stroke Conference that took place in Honolulu earlier this year, where St. Jude touted new findings that patients with the Amplatzer device had fewer and smaller strokes than patients who received drug therapy alone.
The Amplatzer device was designed to treat a condition called patent foramen ovale, in which a naturally-occurring hole in the heart fails to close after birth, potentially allowing blood clots to travel from 1 side of the hart to the other and then to the brain, causing a stroke.