St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the presentation of additional data from its landmark RESPECT trial at the American Stroke Association’s International Stroke Conference 2013 in Honolulu. The RESPECT trial evaluated whether closing an opening in the heart, called a patent foramen ovale or PFO, with the AMPLATZER ™ PFO Occluder lowered the patient’s risk of having another stroke.
“Data from the RESPECT 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,” said Dr. Jeffrey L. Saver, director of the UCLA Stroke Center and professor of Neurology at the David Geffen School of Medicine. “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.”
An ischemic stroke occurs when a blood clot blocks a vessel, interrupting blood flow to an area of the brain (the other type of stroke is hemorrhagic, which occurs when a blood vessel in the brain ruptures). When a blood clot blocks a vessel, brain cells begin to die and brain damage can occur. The origin of the blood clot can impact where it becomes lodged in the brain, thereby creating strokes in different areas. A paradoxical embolism occurs when a blood clot travels from the right side of the heart to the left side of the heart, often through a PFO, and can then travel directly to the brain, causing an ischemic stroke. Statistics from the World Health Organization show an estimated 15 million strokes occur worldwide each year, of which approximately 80 percent are ischemic.
The purpose of analyzing these additional data from the RESPECT 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 confirm that patients with a device in place were less likely to suffer another stroke and patients in the medical group experienced larger strokes. PFO closure with the AMPLATZER PFO Occluder demonstrates clinical evidence of risk reduction and is an important option for the prevention of recurrent stroke in carefully selected patients over conventional medical management alone.