GORE® CARDIOFORM Septal Occluder used in REDUCE trial returns positive results


According to recent Gore announcement, their PFO closure device  showed a statistically significant reduction in stroke recurrence in the primary intent-to-treat analysis.  Read the full Gore press release here…

 

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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/

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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

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.

PFO Closure Poll Results Favorable (So Far)


A while back we asked you to take this poll….

Have You Had PFO Closure?  Take Our Quick Poll:


Many patient’s report improvement in symptoms and sometimes even complete resolution of symptoms after PFO closure, while other patients report mixed results.  If this applies to you, I hope you’ll chime in here how you feel after closure in this very unscientific anonymous poll:


 

So now for a quick PFO Closure Poll update, here’s how the polling results are going so far (340 responders to date)…

PFO Closure Poll Results at Know-Stroke.org
PFO Closure Poll Results at Know-Stroke.org

 

FDA Announces First-Ever Patient Engagement Advisory Committee


FDA Announcement on New Patient Engagement Initiative

Source FDA

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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