PFO Closure With the AMPLATZER™ PFO Occluder


What Is a Patent Foramen Ovale (PFO)?

Before birth, there is an opening in the form of a tissue flap in the wall between the left atrium and right atrium (upper chambers) of the baby’s heart. This opening (“foramen ovale”) allows oxygenated blood from the mother to bypass the baby’s lungs, which do not function until birth. When the baby is born, this flap opening typically closes, and is completely sealed within a few months.

When the foramen ovale does not close completely, it is called a “patent foramen ovale” (PFO).

A patent foramen ovale occurs in about 25% to 30% percent of people (1 in 3 to 4 individuals).1


A PFO can allow a small amount of blood to pass from the right side of the heart to the left side of the heart. In the vast majority of individuals, a PFO causes no medical problems, and if discovered incidentally, requires no treatment or follow-up.

Graphic showing a patent foramen ovale in a heart between the right and left atriums

An ischemic stroke occurs when a blockage develops in a blood vessel carrying blood to the brain.


PFOs and Strokes

Although PFOs are very common in the general population, this small opening within the heart can, in rare cases, allow a blood clot to pass from the right side of your heart to the left side of your heart, and then travel to the brain where it can block a blood vessel, resulting in a stroke.

A cryptogenic stroke is a type of ischemic stroke in which a specific cause (such as atherosclerosis or atrial fibrillation) is not found. The presence of a PFO is believed to be a factor that could lead to an ischemic stroke that would otherwise be called cryptogenic.


Understanding Your Treatment Options

Your doctor will perform several important tests to look for the common and uncommon causes of ischemic stroke to guide your treatment. If the results of your testing did not identify any of the likely known causes of stroke, your neurologist and cardiologist have concluded that you have had a cryptogenic stroke. Because you have a PFO, your doctors believe you should consider closure of your PFO, among other treatment choices, to reduce the risk of having another ischemic stroke.

Please discuss any questions you have with your doctor to determine which treatment option is right for you.

Download our guide for patients and caregivers to learn about the St. Jude Medical approach to PFO closure.

Cover of the AMPLATZER PFO Occluder patient information guide

Closure With the AMPLATZER™ PFO Occluder

The AMPLATZER™ PFO Occluder is a device that can be placed in your heart to close the PFO through a minimally invasive, catheter-based technique. In the major study to evaluate the safety and effectiveness of the AMPLATZER™ PFO Occluder, most patients who were treated with the device also took blood thinning medications (aspirin and clopidogrel for one month followed by aspirin alone indefinitely).

Watch our video to see how a PFO may allow blood clots to enter vessels in the brain, potentially triggering a stroke, and how the minimally invasive AMPLATZER™ PFO Occluder can reduce your risk of recurrent stroke.

Indoor shot of St. Jude Medical office in Austin, TX.

 

About St. Jude Medical

St. Jude Medical is a medical device company committed to advancing the treatment of some of the world’s most expensive epidemic diseases, including congenital heart defects like patent foramen ovales. We are proud to be a market leader in the research, design and development of cardiovascular and other solutions for patients of all ages worldwide.

Learn more about St. Jude Medical

Rx Only
Brief Summary: Prior to using these devices, please review the Clinician’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications for Use: The AMPLATZER™ PFO Occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke.
Contradictions: Patients with intra-cardiac mass, vegetation, tumor or thrombus at the intended site of implant, or documented evidence of venous thrombus in the vessels through which access to the PFO is gained. Patients whose vasculature, through which access to the PFO is gained, is inadequate to accommodate the appropriate sheath size. Patients with anatomy in which the AMPLATZER™ PFO device size required would interfere with other intracardiac or intravascular structures, such as valves or pulmonary veins. Patients with other source of right-to-left shunts, including an atrial septal defect and/or fenestrated septum. Patients with active endocarditis or other untreated infections.
Adverse Effects: Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: air embolus, headache/migraine, allergic dye reaction, hypertension/hypotension, allergic drug reaction, myocardial infarction, allergic metal reaction (nickel, titanium, chromium, iron, manganese, molybdenum), anesthesia reactions, pacemaker placement secondary to PFO device closure, apnea, palpitations, arrhythmia, pericardial effusion, bacterial endocarditis, pericardial tamponade, bleeding, pericarditis, brachial plexus injury, peripheral embolism, cardiac perforation, pleural effusion, cardiac tamponade, pulmonary embolism, cardiac thrombus, reintervention for residual shunt/device removal, chest pain, sepsis, device embolization, stroke, device erosion, transient ischemic attack, deep vein thrombosis, thrombus, death, valvular regurgitation, endocarditis, vascular access site injury, esophagus injury, vessel perforation and fever.
Clinician’s Manual must be reviewed for detailed disclosure.

REFERENCES


1. St. Jude Medical. Data on file. SJM-AMPLP-0716-0001(1)
2. American Heart Association. (2016). Ischemic Stroke (Clots). Retrieved from http://www.strokeassociation.org/STROKEORG/AboutStroke/TypesofStroke/IschemicClots/Ischemic-Strokes-Clots_UCM_310939_Article.jsp#.V88-MPkrJhE
3. American Heart Association. (2016). Patent Foramen Ovale (PFO). Retrieved from http://www.heart.org/HEARTORG/Conditions/More/CardiovascularConditionsofChildhood/Patent-Foramen-Ovale-PFO_UCM_469590_Article.jsp#.V882FvkrJhE