Only FDA-Approved Device to Repair "Hole in the Heart" Condition Now Available at Baylor Heart and Vascular Services at Fort Worth

Condition Affects One in Four Adults, Device Prevents Blood Clots and Reduces Recurrent Cryptogenic Stroke Risk

Baylor Heart and Vascular Services at Fort Worth on Tuesday, November 15, became the first program in Texas to implant the only FDA-approved device designed to prevent blood clots from entering the brain by sealing a hole in the heart. The device is designed to help reduce the risk of recurrent cryptogenic strokes in patients diagnosed with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart.

The Baylor Hamilton Heart and Vascular Hospital team implanted this new device – the AMPLATZER™ PFO Occluder – into two patients with PFO at Baylor Scott & White All Saints Medical Center – Fort Worth.

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.  

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 twenty-five percent of adults have a PFO, which is often not detected until they have a stroke from an unknown cause, also known as a cryptogenic stroke. 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.

About Baylor Jack and Jane Hamilton Heart and Vascular Hospital
Baylor Hamilton Heart and Vascular Hospital opened in 2002 as the first North Texas hospital dedicated solely to the care and treatment of heart and vascular patients.  The hospital provides inpatient and outpatient services focused on preventive health care and comprehensive cardiovascular disease management.  In 2014 Baylor Hamilton Heart and Vascular Hospital expanded to serve the needs of the Fort Worth community at Baylor Scott & White All Saints Medical Center. Baylor Heart and Vascular Hospital now offers quality heart care including heart catheterization and electrophysiology and cardiac diagnostic procedures.

Notice regarding physician ownership:  Baylor Jack and Jane Hamilton Heart and Vascular Hospital is a hospital in which physicians have an ownership or investment interest.  The list of physician owners or investors is available upon request.  Physicians are members of the medical staff at one of the Baylor Scott & White Health subsidiary, community or affiliated medical centers and are neither employees nor agents of those medical centers, Baylor Hamilton Heart and Vascular Hospital or Baylor Scott & White Health.

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About Baylor Scott & White Health
As the largest not-for-profit health system in the state of Texas, Baylor Scott & White promotes the health and well-being of every individual, family and community it serves. It is committed to making quality care more accessible, convenient and affordable through its integrated delivery network, which includes the Baylor Scott & White Health Plan, Baylor Scott & White Research Institute, the Baylor Scott & White Quality Alliance and its leading digital health platform – MyBSWHealth. Through 51 hospitals and more than 1,200 access points, including flagship academic medical centers in Dallas, Fort Worth and Temple, the system offers the full continuum of care, from primary to award-winning specialty care. Founded as a Christian ministry of healing more than a century ago, Baylor Scott & White today serves more than three million Texans. For more information, visit: BSWHealth.com