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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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

King Wilder, 57, never knew he had a hole in his heart until he had a stroke

Listen to this 911 call and share Mr. Wilder’s  chilling experience of what it feels like to be having a stroke and not be able to communicate.  It was later determined that the cause of his stroke was probably caused from a PFO (patent foramen ovale), or hole in his heart.

 

As shared by The Desert Sun

 

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:

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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:

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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

 

New Report Released : Closure versus medical therapy for preventing recurrent stroke in patients with patent foramen ovale and a history of cryptogenic stroke or transient ischemic attack

PFO Closure vs. Medical Therapy

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Published Sept. 8 2015
Cochrane.org

The authors of this report wanted to compare the safety and effectiveness of transcatheter device closure (TDC) versus medical therapy in people with a patent foramen ovale (PFO) who have suffered a stroke of unknown cause in order to prevent strokes or similar events occurring again.

Key results: The Cochrane Report  found that, “when compared with medical therapy, TDC failed to show any significant benefit in reducing the risk of recurrent stroke or similar events. However, there was a possible protective effect on recurrent strokes in those participants for whom an Amplatzer device was used compared with medical therapy. We did not find evidence that TDC increased the rate of serious adverse events overall. However, TDC increased the risk of new-onset atrial fibrillation (where there is a problem with the rate or rhythm of the heartbeat) and may be associated with the type of device used.”

Read the full Cochrane Report on PFO closure vs. medical therapy 

Authors: 

Li J, Liu J, Liu M, Zhang S, Hao Z, Zhang J, Zhang C

Chime in!  

Have You Had PFO Closure?  Take Our Quick Poll:

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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:

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See Our Previous PFO Poll:

Want to tell Us More about Your PFO Story?

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3D Printing for Better Heart Occluder Placement

What a brilliant idea!  Heartwire by Medscape presented  a case report where Australian physicians are taking advantage of 3D printing to create an exact replica of the patient’s cardiac anatomy when planning left atrial appendage (LAA) closure procedures.

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Can’t help wondering…

Could 3-D printing also be used in other cardiac procedures?

Perhaps to better size PFO occluders prior to placement?

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Here’s the link to the full article:

Personalized 3D Printing of Heart Model Aids in LAA-Closure Procedure: Case Report

Nickel Allergy Reactions in Septal Closure Devices

MedPage Today reported “in a case series in patients undergoing percutaneous ASD [atrial septal defect] or PFO [patent foramen ovale] closure, particularly those with a history of metal allergy, routine nickel allergy testing should be considered to identify patients at higher risk of an exaggerated inflammatory reaction in whom surgical closure may be favored.”

The article went to to report  “symptoms of systemic nickel allergy usually don’t include rash, but often present as a combination of chest pain, breathlessness on exertion, and mild leukocytosis and can include migraine and pericarditis as well.”

Read the full article:

Cardiac Device Explant Clears Nickel Allergy Reactions