Data Says PFO Closure With Amplatzer Lowered Risk Of Recurrent Stroke


In short

St. Jude Medical, Inc. is seeing additional data from its landmark RESPECT trial presented at the American Stroke Association’s International Stroke Conference 2013 in Honolulu.


An ischemic stroke occurs when a blood clot blocks a vessel, interrupting blood flow to an area of the brain. The origin of the blood clot can impact where it becomes lodged in the brain, thereby creating strokes in different areas. A so-called 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 patent foramen ovale (PFO), and can then travel directly to the brain, causing an ischemic stroke.

The RESPECT trial evaluated whether closing the PFO with the AMPLATZER™ PFO Occluder lowered the patient’s risk of having another stroke. As a follow-up, by analysing additional data from the RESPECT trial it was hoped 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. The full release can be found here.

It seems from the results then that 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.

Physician comments

“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.”

Company comments

“The overall trial demonstrates that PFO closure with the AMPLATZER PFO Occluder for these relatively young, otherwise healthy patients substantially reduces their risks of suffering another stroke,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division.

Source: St.Jude medical, Inc. Business wire