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.

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

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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/

What a Journey !

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Body in Balance Principles Help in Recovery

The following is a recent 5 Star Review of Body in Balance on Amazon

I’ve adopted the simple diet an exercise principles outline in the book and used them to fuel my obsession to get better. –March 21, 2016 By Eddie

This review is from: Body in Balance: Bare Naked Truth on Nutrition Fitness and Food Policies Impacting Your Energy and Your Health (Smart Moves Guidebook Series) (Kindle Edition)

“Following a serious spinal cord injury, I received this book as a gift during my stay at a rehabilitation hospital in Boston, Ma. It has become my bible! I’ve adopted the simple diet an exercise principles outline in the book and used them to fuel my obsession to get better. The author, David Dansereau, understands recovery from both a personal and professional level. He is a stroke survivor and a Physical Therapist/Sports Nutritionist. Using this unique background he has put together the ultimate hand book for both recovery and everyday living. Thank you David for your honest straight forward approach to fitness and well being.”

 

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Do You Have a Copy of My Book?

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My Book, Body in Balance is an Amazon Best Seller in Preventive Medicine!

I get asked often, “Is Body in Balance About your Stroke“?

The short answer to this question is “No” but the actual answer is somewhere in between because much of what is in my book came from my own research and experimentation of how to set goals to best restore balance to my body through proper nutrition and therapeutic exercise.  My research can be used by anyone needing to get clear on their goals and follow a game plan to take action getting started on the right path.

Order Your Copy Here  on Amazon for Kindle or Paperback

If you want more help to learn more about goal setting and restoring balance after a stroke register for my free webinar here.

 

Stroke Recovery Goal Setting Action Guide

In my last post I mentioned my book Body in Balance is a great place to find help with how to create an action plan for achieving your own goals.  I forgot to mention I also have a great free stroke recovery goals setting action guide you can access right away with this instant download.  It is part of my home stroke recovery goal setting webinar.  You can still register for the free webinar rebroadcast, download this action guide and get started building smart goals of your own!

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Take Action!

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Buy Now on Amazon!

 

Body in Balance Book

A Plan to Take Action!

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Body in Balance-Amazon Best Seller in Preventive Medicine

Whether you are recovering from short term illness or are struggling with how to maximize your recovery after a more serious  setback like a stroke, you need a plan to take action.   Before you begin, consider using Body in Balance as a guidebook of smart moves to learn how to make effective goals to build your own plan. If you’re like Joe in this video below and you were referred to Body in Balance, then you have a guide to put your plan into action.

Get Your Copy on Amazon.com

If you’ve been helped by my book, I’d like to feature your story, please contact me:

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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

http://www.tctmd.com/txshow.aspx?id=127871&trid=198

Learn More About PFO

Home Stroke Rehab Tip from my Smart Moves Webinar

Home Stroke Rehab Tip for Balance Training

[Source]

How to Restore Balance and Set Smart Goals After a Stroke Webinar

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This quick stroke recovery tip is from the stroke rehab tools and tricks section of my recent home stroke recovery webinar.  This quick video shows how to use an alternate and affordable safe harness system at home for balance retraining and strengthening for under $15 to help with your home stroke rehab exercises.  Join the webinar rebroadcast at http://www.know-stroke.org and sign up for this educational webinar from my Smart Moves Webinar series.  

Note: At the end of the month this rebroadcast will go into my members area and the replay registration will be removed.  Register and watch the rebroadcast to help jump start your home stroke recovery!

Be sure to Check out my New Book on Amazon!