Lafayette General Medical Center Now Offering Device Shown to Reduce Recurrent Ischemic Stroke Risk

10/17/2017

Lafayette General Medical Center (LGMC) is now offering the first and only FDA-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. The AMPLATZER™ PFO Occluder device was 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. LGMC was the first hospital in Acadiana 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.

“With the recent FDA approval for this new device we can now offer a definitive treatment for patients with a PFO who had a stroke from an unknown cause,” said Louis Salvaggio, M.D., an Interventional Cardiologist with Cardiovascular Institute of the South (CIS), who performed the procedure at LGMC.  “By closing the PFO we can reduce a patient’s risk for future strokes.  I’m excited to be able to offer this procedure.”

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 partnership between Lafayette General and CIS means great things for our patients,” said Patrick Gandy, Jr., CEO of LGMC. “I commend Dr. Salvaggio on being the first physician in our region to perform the procedure.  We are reducing stroke in our community and that’s a terrific thing to be part of.”

The AMPLATZER PFO Occluder, from global medical device manufacturer Abbott (formerly 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, please visit http://www.pfoamplatzer.com/.

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