Archives     Advertise     Editorial Calendar     Subscribe     Contact Us    


FDA Approves Device for Prevention of Recurrent Stroke in PFO Patients


 

On Oct. 28, the U.S. Food and Drug Administration approved the Amplatzer PFO Occluder device. The PFO Occluder reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot that passed through a small hole in the heart, called a patent foramen ovale (PFO), and then traveled to the brain.

"The Amplatzer PFO Occluder provides a non-surgical method for doctors to close a PFO," said Bram Zuckerman, M.D., director of the Division of Cardiovascular Devices in the FDA's Center for Devices and Radiological Health. "But as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke and help ensure that PFO closure with the device is likely to assist in reducing the risk of a recurrent stroke."

About 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). However, in some patients, medical tests cannot identify the cause of the stroke, which is referred to as a cryptogenic stroke. In a small percentage of these patients, it is believed that the PFO provided a path for a blood clot to travel to the brain where it blocked a blood vessel resulting in a stroke. Patients with a cryptogenic stroke and a PFO may be at an increased risk of having a second 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 top right chamber (right atrium) and the top left chamber (left atrium). The device had been on the market more than a decade ago under a humanitarian device exemption (HDE), but was voluntarily withdrawn by the manufacturer in 2006 after the FDA concluded that the target population for this device was greater than 4,000 patients and that the device no longer qualified for an HDE approval. For the past 10 years, no FDA-approved heart occluder devices have been on the market specifically indicated to close PFOs to reduce the risk of a recurrent stroke in patients with a prior cryptogenic stroke.

In approving the Amplatzer PFO Occluder, the FDA concluded that the device demonstrated a reasonable assurance of safety and effectiveness. The safety and efficacy was assessed in a randomized study that evaluated 499 participants aged 18 to 60 years old who were treated with the Amplatzer PFO Occluder plus blood-thinning medications compared to 481 participants who were treated with blood-thinning medications alone. While the rate of new strokes in both treatment groups was very low, the study found a 50 percent reduction in the rate of new strokes in participants using the Amplatzer PFO Occluder plus blood-thinning medications compared to participants taking only blood-thinning medications.

Adverse effects associated with the device or the implantation procedure include injury to the heart, irregular and/or rapid heart rate (atrial fibrillation), blood clots in the heart, leg or lung, bleeding and stroke.

The Amplatzer PFO Occluder device should not be used in patients with a heart valve infection or other untreated infections, or a heart tumor or blood clot at the implant site. The device is also contraindicated in patients with other abnormal connections between the heart chambers or in whom the cardiovascular anatomy or blood clots would interfere with the ability to move the catheter used to deliver the device to the heart.

Patients should discuss with their medical team (consisting of a neurologist and a cardiologist) the risks and benefits of PFO closure in comparison to using medications alone.

The Amplatzer PFO Occluder device is manufactured by St. Jude Medical Inc. based in Plymouth, Minnesota.

 
Share:

Related Articles:


Recent Articles

Cancer Care on the Cutting Edge

Nashville physician-scientists are helping lead the way in advancing cancer care.

Read More

The Evolution of Senior Living

The senior living industry is undergoing a makeover as baby boomers shift focus from medical-directed care to hospitality-driven services.

Read More

When Basic Science Becomes a Breakthrough

Noted immunologists joined forces at the recent International Cancer Immunotherapy Conference to discuss the importance of fostering and funding basic science.

Read More

Dr. Meredith McKean Brings New Hope, More Options for Melanoma Patients

Oncologist Meredith McKean, MD, MPH, overseeing Sarah Cannon's Melanoma Research Program

Read More

ONcology Rounds

News of note in cancer research, treatment and partnerships.

Read More

Ascension Saint Thomas Opens Cancer Center

Ascension Saint Thomas recently celebrated the grand opening of their comprehensive new cancer center on the Midtown campus.

Read More

NMGMA 10 Minute Takeaway

Medicare Part B representative from Palmetto GBA offered updates and resources to navigate compliance.

Read More

Improving Quality, Lowering Cost of Care for Seniors

Five years into the Medicare Shared Savings Program, more and more ACOs are beginning to demonstrate the ability to improve quality while lowering costs.

Read More

Planning Ahead: Patients & Power of Attorney

The time to think about a durable power of attorney is long before it's needed. Barbara Moss discusses the importance of the document in healthcare.

Read More

Council on Aging Honors Middle Tennesseans

The Council on Aging (COA) of Middle Tennessee hosted their 27th Annual Sage Awards on Oct. 29. With a belief that aging should be celebrated and embraced and that older adults have a lifetime of wisdom and experience to offer communities, the Sage Awards are presented each year to older adults who have made outstanding contributions to Middle Tennessee.

Read More

Email Print
 
 

 

 


Tags:
Amplatzer PFO Occluder, Blood Clot, FDA, FDA Approval, Patent Foramen Ovale, PFO, Recurrent Stroke, St. Jude Medical Inc., Stroke
Powered by Bondware
News Publishing Software

The browser you are using is outdated!

You may not be getting all you can out of your browsing experience
and may be open to security risks!

Consider upgrading to the latest version of your browser or choose on below: