An important CardioVisual collaborator recently received FDA approval for a device that corrects a heart defect and eliminates the need for a lifetime of blood thinner use.

Abbott (formerly St. Jude Medical) developed the Amplatzer PFO Occluder to seal a hole in the heart that can be a problem for certain patients.

The foramen ovale is a hole in the wall between the left and right atria of every human fetus. This hole allows blood to bypass the fetal lungs, which cannot work until they are exposed to air. For most newborns, this hole closes and is completely sealed the second the baby takes her first breath. However, in 25% of us, this hole does not close, and the open hole is known as a patent foramen ovale or PFO.

PFO is not a problem in the vast majority of people who have the condition, even though blood is leaking from the right atrium to the left. However, problems can arise when that blood contains a blood clot. If a clot travels from the right side of the heart to the left, it might then travel to the brain and result in a stroke.

The Amplatzer PFO Occluder is designed to seal the PFO in patients who are at risk for recurrent strokes and who don’t wish to take blood thinners indefinitely.  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.

“The Amplatzer PFO Occluder underscores St. Jude Medical’s commitment to advancing therapies designed to improve long-term quality of life and reduce health care costs,” said Mark D. Carlson, M.D., Division Vice President and Chief Medical Officer at Abbott. “The approval of the Amplatzer PFO Occluder is an important step for patients living in fear of recurrent stroke as a result of a PFO, and offers physicians more options to help their patients make decisions that best fit their lives.”

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.

The Amplatzer PFO Occluder was approved by the U.S. Food and Drug Administration in November 2016 for commercial use in the U.S. to reduce the risk of recurrent ischemic stroke in patients predominately between the ages of 18 and 60 years, who have had a stroke likely related to a PFO, as determined by a neurologist and cardiologist following appropriate evaluation.

CardioVisual founder Dr. Manish Chauhan, MD, FACC, is a firm believer in new medical technologies and treatments to reduce risk of heart attack as well as stroke.

Dr. Chauhan immediately added to the CardioVisual app a video explaining how PFO causes stroke and how the Amplatzer device works. “This is an important advancement in the treatment of PFO, and it was essential that we share information about this device to as many doctors and patients as possible,” he says. “This simple procedure will have a far-reaching impact on many patients’ lives.”