News | Structural Heart Occluders | February 01, 2017

Amplatzer PFO Occluder Now Available at Baylor Heart and Vascular Services at Fort Worth

First two Texas patients received device designed to reduce the risk of recurrent cryptogenic strokes in November

Amplatzer PFO Occluder, St. Jude Medical, Baylor Heart and Vascular Services, Fort Worth, Texas, first patients

February 1, 2017 — Baylor Heart and Vascular Services at Fort Worth in November became the first program in Texas to implant the Amplatzer PFO Occluder. 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 the new device into two patients with PFO at Baylor Scott & White All Saints Medical Center – Fort Worth.

The Amplatzer PFO Occluder is the first and only U.S. Food and Drug Administration (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 25 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 percent over guideline-directed medical therapy alone.

Placement of the device 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.

For more information: www.sjm.com

Related Content

Teleflex Launches Next-Generation Sympro Elite and Expro Elite Snares
Technology | Cath Lab | February 07, 2018
Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and U.S. commercial launch...
SCAI Advocacy Committee Highlights Reimbursement Reform Efforts in 2017
News | Cath Lab | January 30, 2018
The Society for Cardiovascular Angiography and Interventions (SCAI) highlighted the efforts of its Advocacy Committee...
IAC Releases Cardiovascular Catheterization Accreditation Program
News | Cath Lab | January 25, 2018
January 25, 2018 – The Intersocietal Accreditation Commission (IAC) announced the release of its Cardiovascular Cathe
Videos | Cath Lab | January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab | January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab | November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab | November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab | November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab | November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Overlay Init