FDA approves Amplatzer

News announcement from FDA you’ll be interested in if you’ve suffered a cryptogenic stroke from a suspected PFO and need more choice for treatment.

Update to Recent Post: Long Journey to Improve PFO Patient Voice and treatment Options for Cryptogenic Stroke

Wow, I have personally spent lots of time advocating for this important stroke/PFO patient matter over many, many years but hard work has now paid off.  The FDA announced last week the Amplatzer is now finally approved for recurrent cryptogenic stroke treatment in certain PFO patients!

Congrats and recognition for the commitment from the original team of PFO patients (formerly PFO Research Foundation in the US) that I began this important advocacy journey on with together so many years ago. Thank you!

Read the FDA Notice:


Take look back at my FDA testimony and this PFO journey background here:


What a Journey !

New American Academy of Neurology (AAN) Guidelines on PFO Closure in Cryptogenic Stroke are Discouraging

David Dansereau
David Dansereau (Know-Stroke.org)

AAN Ruling Again on P values NOT Patient Values

[In my opinion this is very discouraging news and more evidence to show there is still a great divide in how neurologists and cardiologists treat cryptogenic stroke with known PFO.]

PFO Closure Tipping Point

Despite the hard work of PFO patients (like myself) to make a difference by providing testimony and  their real life perspectives to the FDA recently, it looks like the AAN is unmoved and keeping with their same position on how to best mangage and educate patients that have had a cryptogenic stroke with confirmed  PFO.


Read the post of this news from TCTMD


FDA Circulatory System Devices Panel Votes to Approve Amplatzer PFO Occluder

Post by David Dansereau,MSPT


On May 24,2016 I provided patient testimony at the Circulatory System Device Panel at the FDA along with Bray Patrick-Lake and Peggy Mahrt of the PFO Research Foundation and several other patients who also traveled to Washington DC to share their stories.

Bray Patrick-Lake, David Dansereau,Peggy Mahrt provided patient testimony at the FDA Circulatory Device Panel for Amplatzer PFO Occluder. Photo courtesy of PFO Research Foundation


I wanted to share my FDA  testimony and my story of why it may finally be time to change my Facebook profile photo in today’s post on know-stroke.org

David Dansereau of Know-Stroke.org
David Dansereau of Know-Stroke.org

FDA Announces First-Ever Patient Engagement Advisory Committee

FDA Announcement on New Patient Engagement Initiative

Source FDA


Today the FDA is announcing the establishment of the Patient Engagement Advisory Committee (PEAC) to help assure that the needs and experiences of patients are included as part of the FDA’s deliberations on complex issues relating to the regulation of medical devices and their use by patients.

While patient representatives participate in many FDA advisory committee meetings, the FDA has never had a committee that was wholly focused on patients. Rather than focusing on a product or specific disease, the new committee will be asked to weigh in on a variety of important patient-related issues. The FDA is asking the public to comment on which issues the committee should focus on first.

The FDA is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the committee. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. For information about how to nominate yourself or another candidate to participate in the Committee please see the Federal Register notice.

For more information about additional ways that CDRH is engaging patients, see the CDRH Patient Engagement webpage.

For more information about the Patient Engagement Advisory Committee, see the Patient Engagement Advisory Committee webpage.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health

Amplatzer cardiac plug “very promising device” study suggests

Amplatzer Plug Cuts Stroke, Bleeding Risks in AFib

According to Study

Almost eight years out post pfo closure and the hairs on the back of my neck still stand up when I get an “Amplatzer” Google alert.  I guess it will always be that way until we get better guidelines and follow-up for PFO patients.


This alert however was for a large registry study on the Amplatzer plug for left atrial appendage (LAA) closure.  Read the full report as posted today in TCTMD by Todd Neale.  Caution is warranted despite positive findings of this study. As always, it is wise to always read the full disclosures of those involved for any potential conflicts of interest.


Related Resources:

Search all PFO posts on this blog


Learn More About PFO
Learn More About PFO

A Year in Review- Still No Closure on PFO Closure!!

 PFO Closure Progress:

Still in the Dark Ages?

These PFO posts still remain two of my most popular posts in 2014 according to WordPress site stats for “Year in Review” which makes me sad actually because it probably means folks are still looking for closure on PFO closure (2 years after the original PFO closure/”Dark Ages” post and 4 years after the PFO Exercise Guidelines post)!

Wish the medical community could do much better for PFO patients:(

Source: Know-Stroke.org






Body in Balance
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Statin Drugs and Stroke Prevention: What to Do Now?

by David Dansereau for www. know-stroke.org

There were new guidelines announced earlier this week for statin therapy and heart disease /stroke prevention that would by some estimates double the number of Americans on cholesterol-lowering medications.  Statin drugs are already amongst the most widely prescribed medications in the world.

Dr. Sanjay Gupta of CNN tweeted whether we are “waving the white flag” when it comes to helping Americans avoid heart disease.

Dr. Eric Topol, a cardiologist and chief academic officer of Scripps Health, also tweeted that the doubling of patients on statins, which can lower cholesterol by up to 50%, was “not good.”

I suggested in a recent tweet that taking the time to learn how to eat to lower inflammation may make better sense as a first line defense before you pop yet another pill as a patch to cover your poor diet.

What the new Statin guidelines mean:

Under these new guidelines, people without a history of heart disease can start taking statins if they have a 7.5% higher risk of developing heart problems or stroke in the next 10 years, based on their cholesterol levels, blood pressure, weight, gender, race and smoking status. (You can calculate your 10-year risk here but take note it is not an easy thing to understand.)  Perhaps an infographic or better yet I ‘d suggest a convenient app for this might make better sense.  Regardless, the new guidelines for statin use represent a dramatic change from the 20% higher risk that previous guidelines advised.

The new advice also recommends statins for anyone with type 1 or type 2 diabetes, regardless of whether they have additional heart disease risk factors, between the ages of 40 and 75 years old. Diabetes carries a higher risk of heart disease, in part because of the changes in cholesterol levels.  Please check with your doctor because what the news this week didn’t remind us all is these statin drugs have real risks.

How statins work and a reminder of the previous FDA warning on their use

Last year, as reported in an article in the New York Times the FDA added new safety alerts to the prescribing information for statins, citing rare risks of memory loss, diabetes and muscle pain.  It was the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years.

Statin Drug Names and Prescription Numbers

Among the statin drug names are huge sellers like Lipitor, Zocor, Crestor and Vytorin.   Nearly 21 million patients in the United States were prescribed statins last year.   Whether that number of users is too high or too low has been hotly debated as well as the possible financial ties to the panel making statin recommendations.  While advice on whether to take statins involves a complex mix of factors like age, family history and blood pressure, some experts have suggested that those with total cholesterol levels around 200 would benefit from treatment.  Others have argued that treatment should not start until a cholesterol level of 240 or higher, all other factors being equal.

 So, why take a Statin?  What do they do??

Statin drugs inhibit the enzyme HMG-CoA reductase, which plays a central role in the production of cholesterol in the liver. The theory is that lower cholesterol equates to better cardiovascular health, though there has been no actual proven cause and effect and the body needs a healthy amount of cholesterol.  Many recent studies suggest arterial plaque and inflammation are much more likely culprits for heart disease and perhaps simply changing your diet and exercising more could offer the best defense.

What you should ask your Doctor about Statin side effects

Nutrition Education Classes Work! -DP Dansereau Try wmu-101.com
Nutrition Education Classes Work! Enroll at wmu-101.com

Statins have some side effects including a mildly increased risk of diabetes and abnormalities in liver enzyme tests.  Additionally they have rare but severe adverse effects as mentioned in the New York Times article and reported here, which includes  increased risk of muscle damage.

From a nutrition standpoint, statins also inhibit natural production of Co-enzyme Q10 (CoQ10)*, which is vital to good health, particularly muscle health.  One of the most important roles CoQ10 plays is helping the body’s cells produce energy, particularly muscle cells.  As it so happens, the largest and most important muscle in the body is none other than the heart.

*(This is in the fine,fine print of your drug warning and it amazes me still that doctors prescribing this drug don’t mention this to their patients.)

So, should you “wave the white flag” and simply give in and pop a pill?  It is up to you and your doctor to weigh the risks and in the end decide together.  Either way, please don’t give up on your diet and exercise, that’s my bottom line and what I fear will get lost in these new pill guidelines for statins.








more statin articles on this site