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:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm527096.htm

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

http://www.know-stroke.org/a-long-journey-to-improve-pfo-patients-voice-and-treatment-options-for-cryptogenic-stroke/

bostonfinishlinedansereau
What a Journey !
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FDA Circulatory System Devices Panel Votes to Approve Amplatzer PFO Occluder


Post by David Dansereau,MSPT

Know-Stroke.org

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

Is PFO closure now a black hole for medicine?


-by David Dansereau,MSPT  Know-Stroke.org

I admit, I was drifting in thought as I watched the movie Interstellar with my boys over the weekend. The 2014 movie stars Matthew McConaughey who plays Cooper, an ex-pilot who must leave his family on Earth behind to lead an expedition beyond our galaxy through a black hole to discover whether mankind has a future among the stars. My boys love space movies and usually I am guilty of falling fast asleep between the two of them by 30 minutes in, but this movie kept me awake for nearly 3 hours.  I was thinking if I could speed up time like in the movie, where will PFO closure be 7, 15, 30 years from now? Also, if I could go back in time, would I elect to have PFO closure again?? PFO closure at one time early in my treatment after my stroke was described to me by a treating physician as a condition stuck in a “grey” area of medicine.  Unfortunately, I believe PFO closure, along with research into this area is now changing colors and drifting more from grey to black.  I wonder, does PFO research still have a place in medicine?

pfoblackhole_knowstrokeorgThe black hole

Beyond the issue of reimbursement which has been pulled into the black hole years ago, patients simply looking for best practices on managing a possible pathological PFO  have been left behind too long in the mission to explore and treat PFO’s. The medical community has mostly failed us (patients) by not defining a clear patient pathway.  Patient’s have united together over time to try to make a difference.  For example, there have been groups of patient’s that started the PFO Research Foundation out of frustration and lack of united efforts by the medical community to hear patient’s voices. I disclose I was once part of this patient group at the beginning.  Currently, however,  many of these patient efforts remain “under construction” like the vessel being constructed in Intersteller  in attempt to bring humans to a better place. There have also been many smaller, all well intended, social media groups that have entered the PFO galaxy trying to fill the void left by medicine.  Several PFO debate and support groups surrounding the condition have spun off from migraine and stroke to other possible related disorders.  All either lack anything new to report, or the ability to gather new  funding resources to lead serious PFO patient directed research groups like this forward.    At the same time, most physicians that remain in the PFO space continue to argue and take sides over best practices for management.  Either way, the PFO closure debate slowly is making almost no measurable progress and patients are still left to look to the internet for best practices, like Cooper did to space, for answers.  While some patients along with their physicians await FDA ruling, many physicians caught in the controversies that surrounds PFO closure have already made up their mind and stopped doing PFO closure procedures as reimbursement has dried up.   Some have  simply dismissed the option from the start, others are waiting and holding their opinions silent adrift in a black hole of sorts.

While we all wait, there has been some new data and PFO research analysis conducted by pooling data.  There are also a few international studies and groups slowly trying to collect, analyze and report new data.  I wish, however, as do many PFO patients waiting on the launchpad here in the U.S.,  that we could somehow rocket this effort forward much faster so we are not looking back like Cooper at a lifetime that has passed him by trying to solve a problem.

A video guide to learn about patent foramen ovale (PFO) and learn about resources and related health topics.


Know about PFO (patent foramen ovale) and related heart and brain topics of interest to your health.

More videos just added:

Watch new videos to know about patent foramen ovale (PFO) and learn about resources and related health topics.

PFO/Migraine/Stroke Discussion not on RI Stroke Conference Agenda


AHAknowstrokeorg

What would you like to say?

As someone perhaps concerned about the future research on the PFO/Migraine/Stroke connection please help me evaluate the stroke conference I attended yesterday for the PFO Research Foundation.  As I previously mentioned in a post on our patient advocacy group, I attended the 3rd Annual Rhode Island Stroke Conference: “Getting to the Heart of STROKE“. Even though my blood pressure has now returned to baseline I do find myself hitting these keys a bit hard now so please chime in here and help write up my course evaluation. I know you were not there but just knowing the words PFO/Migraine/Stroke were not even mentioned together once at the conference should hopefully get you all going too.

Perhaps if I get enough feedback I’ll build a page and link it to my evaluation for some possible future consideration in conference planning. Pls share!

If not You, Then Who?

David Dansereau

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

Video Update on PFO Clinical Trials this Year


Shared with permission from PFO Research Foundation.

Be sure to visit the PFO Research Foundation website at pforesearch.org

The Future of PFO Closure: Is the Glass Half Full or Empty?


Was the PFO tipping point reached with the results of the recent RESPECT Clinical Trial?

PFO Closure Tipping Point

Not Sure, because if you gather all the recent PFO press headlines you’ll still be left wondering what it all means.  Here’s a sampling:

St. Jude Device to Close Heart Holes Fails to Prevent Stroke BloombergNeither study determined that St. Jude’s Amplatzer PFO Occluder significantly reduced risk of a second stroke. One, funded by the St. Paul Minnesota-based
Study shows PFO closure may be superior to medical therapy in  EurekAlertThe condition is usually not treated unless there are other heart problems or the person has a stroke caused by a blood clot. PFO has been a suspected cause
St. Jude Device to Close Heart Holes Fails to Prevent Stroke BusinessweekNeither study determined that St. Jude’s Amplatzer PFO Occluder significantly reduced risk of a second stroke. One, funded by the St. Paul Minnesota-based company, found the device was beneficial once researchers adjusted the data to consider different
St. Jude Medical RESPECT Trial for PFO Closure Provides Clinical MarketWatchwhich studied the AMPLATZER(TM) PFO Occluder in the prevention of recurrent sponsored by the Cardiovascular Research Foundation, shows that the
Study shows PFO closure may be superior to medical therapy in Medical XpressAccording to the National Institutes of Health, a PFO is a hole between the left PFO has been a suspected cause of cryptogenic stroke, meaning a stroke

If you want RESPECT as a PFO (patent foramen ovale) patient you’ll have to tell your story loud and clear.  If you think the tipping point is here and you want your story to matter please tell it here.  I’m compiling a selection of  compelling patient stories to present in a new format.  If you’ve already shared your PFO/stroke/migraine story on my blog recently I thank you and encourage you to send in an update.  If you’d like more information use the form below or simply copy and paste your story if it is ready to go.  Thank You!