A Salina doctor is using new break through technology to help reduce the risk of stroke in some at-risk patients. Mowery Clinic Cardiologist, Dr. Maria Baldasare is now offering a newly-approved device designed to help reduce the risk of recurrent ischemic strokes in patients diagnosed with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart.
According to Mowery Clinic, the AMPLATZER™ PFO Occluder is the first and only FDA-approved device designed to close the PFO and lower the risk of stroke caused by dangerous clots passing between the heart chambers and up to the brain. Dr. Baldasare was the first Cardiologist in the Salina region to implant the device since the product’s approval.
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.
“We are very excited to have this new technology available at SRHC,” said Dr. Maria Baldasare, an Interventional Cardiologist who performed the procedure. “The recent data that just came out showed that closing patent foramen ovale in the right patients has proven superior to medical therapy.”
It is estimated that twenty-five 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% over guideline-directed medical therapy alone.
Placement of the AMPLATZER PFO Occluder is minimally invasive and performed while the patient is sedated but still conscious. Data from the RESPECT trial also show that PFO closure with the device has a low risk of device or procedure-related complications.
The AMPLATZER PFO Occluder, from global medical device manufacturer St. Jude Medical, was approved by the U.S. Food and Drug Administration (FDA) in November 2016 for commercial use in the U.S. For more information, visit http://www.sjm.com/en/professionals/featured-products/structural-heart/structural-heart-occluders/pfo-closure-devices/amplatzer-pfo-occluder.
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