News | Structural Heart Occluders | February 15, 2017

UAB First in Alabama to Implement New FDA-Approved Amplatzer PFO Occluder

Device reduces risk of recurrent ischemic stroke for 25 to 30 percent of Americans who have a patent foramen ovale

University of Alabama at Birmingham, Amplatzer PFO Occluder, first implementation

February 15, 2017 — Doctors at the University of Alabama at Birmingham have implemented the first U.S. Food and Drug Administration (FDA)-approved patent foramen ovale occluder in Alabama. 

A PFO is a hole in the heart that does not close the way it should after birth. During fetal development, a small flap-like opening — the foramen ovale — is normally present in the wall between the right and left upper chambers of the heart. It normally closes during infancy. With the new Amplatzer PFO Occluder, ischemic stroke patients will now have access to a closure device shown to reduce risk of recurrent stroke, rather than relying on medical management alone. 

Baker-Dean Endowed Professor in Interventional Cardiology Massoud Leesar, M.D., performed the first procedure Jan. 25, 2017. 

“This new device has the potential to help many patients who suffer from PFO and stroke,” he said. “Our first patient did very well and was discharged the day after the procedure since the echocardiogram showed complete closure of PFO.” 

Approximately 25 to 30 percent of Americans have a PFO, which typically causes no health problems and does not require treatment. The cause of most strokes can be identified, such as poorly controlled high blood pressure, narrowed blood vessels due to cholesterol deposits and scar tissue (atherosclerosis), or a blood clot caused by an abnormal heart rhythm (atrial fibrillation).

“Stroke in patients younger than 60 years old is most likely related to PFO,” Leesar said. “In patients older than 60, other causes such as atherosclerosis and atrial fibrillation will need to be ruled out. These patients are typically referred by neurologists who cannot define other causes for stroke.” 

The Amplatzer PFO Occluder is inserted through a catheter that is placed in a leg vein and advanced to the heart. It is then implanted close to the hole in the heart between the right atrium and the left chamber. The procedure is minimally invasive, and recovery time is minimal.

Nearly 795,000 new or recurrent strokes occur every year in the United States, making it the fifth-leading cause of death and leading cause of serious long-term disability for Americans, according to the American Heart Association. Ischemic strokes account for 87 percent of strokes, and occur when a blood vessel is obstructed, depleting the brain of its blood supply.

The Amplatzer PFO Occluder is developed by St. Jude Medical Inc.

For more information: www.sjm.com 

Related Content

New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Mobility May Predict Elderly Heart Attack Survivors' Repeat Hospital Stays
News | Cath Lab | April 23, 2019
Determining which elderly heart attack patients take longer to stand from a seated position and walk across a room may...
FDA Releases New Guidance on Medical Devices Containing Nitinol
News | Cath Lab | April 18, 2019
April 18, 2019 — The U.S.
Angiography shows a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL lithoplasty.

Figure 2: Angiography demonstrates a stenotic lesion in the mid right coronary artery, undilatable by standard high-pressure balloon angioplasty (inset, arrowheads). (B) Optical coherence tomography (OCT) cross-sectional (top) and longitudinal (bottom) images acquired before IVL and coregistered to the OCT lens (arrow in A) demonstrate severe near-circumferential calcification (double-headed arrow) in the area of the stenosis. (C) Angiography demonstrates improvement in the area of stenosis after IVL (inset; note the cavitation bubbles generated by IVL [black arrows]). (D) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-IVL and coregistered to the OCT lens (white arrow in C) demonstrate multiple calcium fractures and large acute luminal gain. (E) Angiography demonstrates complete stent expansion with the semicompliant stent balloon (inset) without the need for high-pressure noncompliant balloon inflation. (F) OCT cross-sectional (top) and longitudinal (bottom) images acquired post-stenting and coregistered to the OCT lens (arrow in E) demonstrate further fracture displacement (arrow), with additional increase in the acute area gain (5.17 mm2), resulting in full stent expansion and minimal malapposition.

Feature | Cath Lab | April 15, 2019 | Dean Kereiakes, M.D., FACC, FSCAI, and Jonathan Hill, M.D., DISRUPT CAD III Co-Principal Investigators
Over the last 40 years, despite multiple advancements in percutaneous coronary interventions, calcified lesions remai
BIOTRONIK’s PK Papyrus covered coronary stent. The stent ius used in emergency coronary artery dissections to repair the vessel wall.
Technology | Cath Lab | April 15, 2019
April 15, 2019 — Biotronik began its U.S.
Providing Follow-Up Care After Heart Attack Helps Reduce Readmissions, Deaths
News | Cath Lab | April 09, 2019
A program designed to help heart attack patients with the transition from hospital to outpatient care can reduce...
Overlay Init