FDA approves first-ever device specifically designed for PFO closure
BOSTON (November 1) – In a late-breaking clinical trial presentation today at the Cardiovascular Research Foundation’s TCT2016 Meeting in Washington D.C., David Thaler, MD, PhD, Neurologist-in-Chief at Tufts Medical Center, shared new data from the decade-long RESPECT Trial, which show for the first time that patent foramen ovale (PFO) closure using the Amplatzer PFO Occluder device is a more effective intervention than medical therapy for reducing stroke risk. In addition to this afternoon’s presentation, the United States Food and Drug Administration (FDA) formally approved the Amplatzer PFO Occluder for PFO closure on October 28, 2016. It is the first such device to be FDA-approved for this purpose.
“This is a potential game-changer for patients with PFO and should have a significant impact on patients’ access to this treatment,” said Dr. Thaler, a member of the RESPECT Trial’s steering committee and the presenting author for the TCT presentation.
The PFO is a small hole in the heart wall between the right and left atria. Every person has a PFO as a fetus, but for most people, the hole will close shortly after birth. However, in about 25 percent of the population, the PFO never closes. This may allow a blood clot to travel through the hole, up to the brain, and cause a stroke. While most people have no symptoms and live their whole lives without ever knowing they have a PFO, 50 percent of patients with strokes of unknown cause have been found to have a PFO.
The RESPECT Trial, which began in 2003, compared PFO closure with medical therapy (such as aspirin or other blood thinners) for the reduction of stroke risk in people between the ages of 18-60 with stroke of unknown origin. Nearly 1,000 people were enrolled in the clinical trial. The new data presented today show that PFO closure with the Amplatzer PFO Occluder device, a procedure that takes less than an hour in a cardiac catheterization laboratory, reduced the risk of stroke by an average of 52 percent – a statistically significant finding that supports the benefits of PFO closure for this patient population.
“Several devices have been used off label to close PFOs, but there never before had been compelling research showing that PFO closure is more effective than medical therapy for stroke prevention,” said Dr. Thaler. “While the early trial data were suggestive, today’s data for the first time show a clear benefit of PFO closure for people with strokes of unknown origin.”
About Tufts Medical Center and Tufts Children's Hospital
Tufts Medical Center is an exceptional, not-for-profit, 415-bed academic medical center that is home to both a full-service hospital for adults and Tufts Children's Hospital. Conveniently located in downtown Boston, the Medical Center is the principal teaching hospital for Tufts University School of Medicine. Tufts Children's Hospital is the full-service children's hospital of Tufts Medical Center and the principal pediatric teaching hospital of Tufts University School of Medicine. Tufts Medical Center is affiliated with the New England Quality Care Alliance, a network of more than 1,800 physicians throughout Eastern Massachusetts. For more information, please visit www.tuftsmedicalcenter.org.
Media Contact: Jeremy Lechan