St Jude Medical has presented additional data from RESPECT trial of its double-disc Amplatzer PFO Occluder device.
Comprised of Nitinol mesh and polyester fabric, the transcatheter patent foramen ovale (PFO) closure device is designed to close all types of PFOs with an easy-to-perform deployment procedure.
The 980 patient-based prospective, randomized event driven-study was designed to determine if PFO closure with the Amplatzer PFO Occluder plus medical management was superior over medical management alone in the prevention of recurrent cryptogenic (unknown cause) stroke.
David Geffen School of Medicine neurology professor and UCLA Stroke Center director Dr Jeffrey Saver said data from the trial indicates that patients with a device were less likely to suffer stroke, had smaller strokes, and were less likely to have the type of stroke linked to paradoxical embolism.
"Indications of preventing strokes on the surface of the brain and large strokes provide additional evidence of a genuine biological effect of closure with the Amplatzer PFO Occluder in preventing recurrent cerebral infarcts due to a blood clot crossing through the PFO," Saver added.
The company said the objective of analyzing the additional data from the trial was to determine if patients in the device and medical therapy group suffered different types of recurrent strokes, and to identify the potential origin of the strokes.
The results showed that patients with a device in place were less likely to suffer another stroke, while patients in the medical group experienced larger strokes.
The company said it has presented the additional study data at the American Stroke Association's International Stroke Conference 2013 held in Honolulu, Hawaii, US.
