Newswise — 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.

About Baylor Scott & White HealthFormed from the 2013 merger between Baylor Health Care System and Scott & White Healthcare, the system referred to as Baylor Scott & White Health is the largest not-for-profit health care system in the state of Texas. With total assets of $9 billion* and serving a population larger than the state of Georgia, Baylor Scott & White Health has the vision and resources to provide its patients continued quality care while creating a model system for a dramatically changing health care environment. The system now includes 47 hospitals, more than 900 access points, 6,000 active physicians, and 44,000 employees, plus the Scott & White Health Plan, Baylor Scott & White Research Institute and Baylor Scott & White Quality Alliance — a network of clinical providers and facilities focused on improving quality, managing the health of patient populations, and reducing the overall cost of care. For more information visit: