Medical Devices

AMPLATZER PFO Occluder - P120021

Image of the device.

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.

Product Name: AMPLATZER PFO Occluder
PMA Applicant: St. Jude Medical, Inc.
Address: 5050 Nathan Lane North, Plymouth, MN 55442
Approval Date: October 28, 2016
Approval Letter:

What is it? The AMPLATZER PFO Occluder is a device that is permanently implanted to close an opening (patent foramen ovale or PFO) between the two upper chambers of the heart (the right atrium and the left atrium). 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 rare cases, a PFO may play a role in the occurrence of strokes. The device is made of two connected circular, self-expanding, nickel-titanium (Nitinol) discs that contain thin polyester fabric.

How does it work? The AMPLATZER PFO Occluder is intended to close a PFO and thus block blood clots from passing from the right atrium to the left atrium. To place the device, a physician first inserts a delivery catheter through a vein in the leg until it reaches the heart. The physician then advances the AMPLATZER PFO Occluder through the delivery catheter and opens the left disc in the left atrium and the right disc in the right atrium. The physician then separates the PFO occluder device from the delivery catheter, removes the delivery catheter from the body, and leaves the occluder device permanently implanted in the heart. The two connected discs close the PFO. Over time, a thin layer of tissue covers the device.

When is it used? PFOs are very common in the general population (occurring in one out of three to one out of four people). In the vast majority of people, PFOs causes no medical problems and do not require treatment. However, a PFO may play a role in the occurrence of strokes in some patients.

Most strokes are caused by a blockage in a blood vessel carrying blood to a part of the brain. Patients who have strokes have medical tests to identify the cause of the stroke (and receive treatments to prevent another stroke), but in some patients, no cause of stroke is found. This is called a cryptogenic stroke. When a cryptogenic stroke occurs in a patient who also has a PFO, it is possible the stroke was caused by a blood clot that passed through the PFO. The AMPLATZER PFO Occluder is intended to be used in conjunction with blood-thinning medications (such as aspirin) to prevent another stroke.

The AMPLATZER PFO Occluder should only be used in cryptogenic stroke patients who also have a PFO after a comprehensive clinical evaluation by a neurologist and cardiologist has ruled out other causes of stroke.

What will it accomplish? The AMPLATZER PFO Occluder was evaluated in a clinical study in which the device plus blood-thinning medication was compared to blood-thinning medication alone. The results showed that the rate of a new stroke was 50% lower in patients treated with the AMPLATZER PFO Occluder plus blood-thinning medication compared to blood-thinning medication alone. The study suggested that if 1000 stroke patients were treated with the device plus blood-thinning medication, about 6 of these patients would have an additional stroke within 1 year compared to about 12 patients who would have an additional stroke when treated with blood-thinning medication alone. However, implanting the AMPLATZER PFO Occluder also carries a risk of complications such as injury to the heart, irregular and/or rapid heart rate, blood clots in the heart, leg or lung, bleeding, and stroke.

When should it not be used? The AMPLATZER PFO Occluder should not be used in patients who:

  1. have a tumor or blood clot at the device implantation site or a blood clot in vessels along the path to the heart;
  2. have blood vessels that are too small to allow performance of the implantation procedure;
  3. have a body organ such as the heart muscle, heart valves, or blood vessels that does not permit placement of the required device size;
  4. have other types of heart defects; and/or
  5. have an infection within the heart or other untreated infections.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online:

Page Last Updated: 11/01/2016
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