The PFO Occluder is the only FDA-approved device designed to prevent blood clots from entering the brain by sealing a hole in the heart

Delray Beach, Fla. (December 6, 2016) - Delray Medical Center is now offering a newly approved device designed to help patients diagnosed with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart. The AMPLATZER™ PFO Occluder is the first and only FDA-approved device designed to close the PFO and reduce the risk of recurrent ischemic strokes caused by dangerous clots passing between the heart chambers and up to the brain.

“Delray Medical Center is proud to be the first hospital in the state to implant this revolutionary device,” said CEO Mark Bryan. “We make it a priority to invest in new technology that may ultimately prolong patients’ lives and enhance their quality of life.”

Normally in a developing fetus, the foramen ovale allows oxygenated blood from the placenta to bypass the lungs. This small, flap-like opening typically closes shortly after birth. When this flap remains open, or “patent,” it is referred to as a PFO. A PFO can potentially allow dangerous clots to pass from the right side of the heart to the left, travel up to the brain and cause a stroke. The AMPLATZER PFO Occluder is designed to seal the unwanted hole and reduce this risk.

It is estimated that 25 percent of adults have a PFO, which is often not detected until they have a cryptogenic stroke (a stroke from an unknown cause). Newly released, long-term data from RESPECT, a landmark clinical trial, showed that patients who received the AMPLATZER Occluder had a reduced risk of recurrent stroke by 45 percent over guideline-directed medical therapy alone. Data from the trial also showed that PFO closure with the device has a low risk of device or procedure-related complications. The procedure to implant the device is minimally invasive and performed while the patient is sedated but still conscious. 

“People who experience a stroke have a 25-35 percent chance of having a recurrent stroke, which often has a higher death and disability rate because parts of the brain are already injured,” said Dr. Brijeshwar Maini, interventional cardiologist and regional medical director of transcatheter therapies for Tenet Healthcare’s Florida Region. “We are pleased to have a new procedure available at Delray Medical Center that can minimize that risk and potentially save many lives.”