What the medical device industry could learn from the auto industry about proper PFO patient care

PFO Patients Need a Comprehensive Care Plan and Owner’s Warranty for Service

Just came from my 5000 mile service check on our new car.  The “Maintenance Required” light had been on for over a week so I quickly scheduled an appointment and got in for an early weekend appointment.  Granted, it was the first time I had the chance  to actually crack the owners manual since buying the vehicle, but take a look at what you get:

  • Owner’s Manual (532 pages)
  • Owner’s Warranty and Rights Notification
  • Vehicle Quick Reference Guide
  • Warranty and Maintenance Guide
  • New Vehicle Delivery Checklist
  • Peace of Mind Toyota Care Benefits (Roadside Assistance and Complimentary Maintenance)
  • App for Roadside Assistance GPS Tracking
Where is the PFO Occluder Owner's Manual for your Heart?
Where is the PFO Occluder Owner’s Manual for your Heart?

Sad that as PFO patients, myself included, we are waiting months to be seen by physicians, wait on hold for calls to insurers to only delay our care and then get sent  denial letters.

Where is our peace of mind? Our Owner’s Manual?  Our PFO Service and Maintenance Manual??

What is our equipment warranty?

How do we know when regularly scheduled maintenance might be required?

After pulling in to a heated bay my door was opened, I was greeted with a friendly “good morning”, my vehicle VIN was scanned and my car was on its way for a quick check-up.  I grabbed a complimentary cup of coffee, perused my owners manual,and even had time to watch a few minutes of SportsCenter.   32 minutes and 18 seconds later I was handed a service report (that’s how I know the time in/out), my name was announced as “Vehicle 236 is leaving the service bay” and I walked out to a tag on my vehicle that matched “236”.  As I drove away to go off to the office (of all things to do get caught up on insurance paperwork), it hit me, I am overdue for a cardiology appointment.  I wonder if I can get a weekend appointment?

So sad….and certainly  the medical device industry could learn a great lesson here.  Especially, as it applies to PFO PATIENT CARE!

Do you have a service plan for your PFO care?  Many of us still don’t even have ID cards…

David Dansereau for Know-Stroke.org


Thanking Jamie for Stepping Up for Pediatric Stroke

Thank You Jamie!

Pediatric Stroke Awareness has a New Bright Mind in the Fight Against Stroke

Faces of Stroke Ambassador Jamie Coyle
Faces of Stroke Ambassador Jamie Coyle

If you’ve been hanging around my stroke blog for some time you know I post often on pediatric stroke awareness and the importance of stroke education for the young faces of stroke.  To get caught up on the subject simply key in the search box on this site for  posts on “pediatric stroke” and see how many articles you’ll find.   I sometimes wonder if  I’m speaking to deaf ears when I challenge  both the National Stroke Association and the American Heart/Stroke Association to “do more”  and allocate resources to fund creative educational programs to improve pediatric stroke awareness.

Well, perhaps someone locally was listening anyway.  Thank you Jamie Coyle for sharing your story and stepping up for Pediatric Stroke Awareness.  For those of you who don’t know stroke survivor and Cumberland RI resident Jamie Coyle here’s the link to her feature story on the National Stroke Association website:   Faces of Stroke-Jamie Coyle

Jamie stepped outside of her comfort zone and while doing so stepped up to the challenge to speak up for stroke. Thank you Jamie and thanks to the National Stroke Association for rewarding her courage!

Posted by David Dansereau,MSPT

for Know-Stroke.org


Bright Minds Pediatric Stroke Education Project

Bright Minds grant proposal for stroke awareness by David Dansereau

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

First-ever group aims to speed medical devices to market

from theHeart.org

Silver Spring, MD – The US Food and Drug Administration (FDA) has unveiled a new nonprofit, public-private partnership that aims to speed safe medical devices to market, in part by encouraging otherwise-competing manufacturers to pool their knowledge about product testing [1].

One example of how this collaboration might bear fruit is the development of a standard computer model of the heart for testing valves and such, said Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a press conference yesterday.

“If I have a model of the heart that includes not only the anatomy but the blood flow and the dynamics of the blood, I can . . . test-drive different configurations of that valve and can get a better understanding of what [it] can do without having to test it in an animal or person initially,” said Shuren. “That can reduce a lot of time and cost in bringing that product to market.

“That’s a winner for patients, for companies, and ultimately a winner for our healthcare system.”

The new partnership, called the Medical Device Innovation Consortium (MDIC), was created by LifeScience Alley, a biomedical science trade association. Founding MDIC members include the FDA, the US Centers for Medicare & Medicaid Services, LifeScience Alley, Medtronic, Boston Scientific, the Pew Charitable Trust, and the National Organization for Rare Disorders. Organizers envision bringing aboard leaders of academia as well as industry and government.

FDA commissioner Dr Margaret Hamburg said at the press conference that MDIC represents the first public-private partnership devoted to improving the science of assessing the safety, efficacy, and quality of new medical devices. Most device makers, Hamburg noted, are much smaller than pharmaceutical companies and have fewer resources for “regulatory science.” There is strength in numbers, however.

“We really needed to create a safe-haven organization to foster precompetitive collaborative research,” she said.

Serving as the interim executive director of MDIC is Dr Maura Donovan, recently the vice president of therapy research and development at Medtronic. Her initial responsibilities will entail recruiting a board of directors and launching subcommittees that will identify and direct specific research projects.
Avoiding the time, expense of animal studies

Shuren said it was premature to talk about research priorities because MDIC has yet to solicit and sift through ideas. However, he threw out two tantalizing hypothetical examples. One was computer modeling of the heart. The second dealt with neurological devices that use implanted electrodes to stimulate the brain and treat disorders such as Parkinson’s disease or help patients control prosthetic limbs with their thoughts.

“One of the challenges, though, is that those electrodes can degrade,” said Shuren. “We didn’t have great tests for assessing them. We don’t want to use people as guinea pigs.”

One answer is conducting tests with an artificial human brain, which is already being developed, he said.

“That would help you to better understand what a particular electrode may do, how durable it is, what the impact may be on the brain . . . and design a better device before it ever gets to patients,” he said. In the process, researchers could avoid the time and expense of less productive animal studies.

MDIC is not related to a nonprofit group with a similar name—the Medical Device Innovation, Safety and Security Consortium.

The complete contents of Medscape Medical News, a professional news service of WebMD, can be found at www.medscape.com, a website for medical professionals.

  1. Food and Drug Administration. FDA announces public-private partnership to develop regulatory science that will speed patient access to new medical device technologies [press release]. December 3, 2012. Available here.

Related links

Source: Heart Wire



So Doc, don’t be so quick to send me home with migraine meds.  Don’t assume your own Doctor is  paying attention to your STROKE Warning signs. KNOW-STROKE!

Why?? Read and Share Derrick Burns Story

originally posted on my Know-Stroke.org Facebook Page

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“Burns had severe headaches for days before his stroke. A few weeks after spring practice concluded, he returned to Pitt for offseason workouts with his teammates. That’s when the headaches came on strong. He went to UPMC for tests. An MRI, CAT scan and spinal tap did not detect anything. He was diagnosed with migraines and sent home.”

Read Derrick Burns stroke story here.  It is so similar to all the stories stroke survivors tell me ( just like Burns) that have suffered with migraines and have been sent home on medication. Unfortunately, like Burns, many are sent home with meds and often told it is “stress related or in their heads” and not investigated further until they have a stroke.

When I tell the survivors I speak to all the time to write down their story, this is why….

(After you read this, put your story on paper, like I tell you (all).   YOU need to speak up and tell your own story and advocate for that voice in your gut that is telling you something just isn’t right.

Read more: http://old.post-gazette.com/pg/12303/1272714-142.stm#ixzz2E2V9ke

Derrick Burns was entering the prime of his college football career. He had just completed his second year at Pitt and was in contention for the starting fullback job after spring practice ended in April. He also had rediscovered his love for the game after two difficult years under former coaches… read more
Reposted by David Dansereau for Know-Stroke.org

Hey Guys, Don’t be a Ditka!

Take Stroke Warning Signs Seriously

Regardless of what Mike Ditka says, STROKE IS a “Big Deal”.

You may have heard recently Mike Ditka had a minor stroke a few weeks back while playing cards at his country club.   This story grabbed some media headlines and it was first reported by Dan Pompei of the Chicago Tribune.  Pompei reported Ditka was at a suburban country club playing cards Friday when he noticed his hands “weren’t working quite right,” and then he had a problem speaking.

[Personal Sidebar] Sorry, just had to put this one in, when I heard Ditka was at his country club when he had a stroke I had an immediate flashback to “Da Bears” on SNL when they spoofed how he minimized the seriousness of his heart attack back in the 80’s.

OK, I’ll get back to the point on this post…

Dan Pompei reported Ditka, 73, has not had any major health problems in recent years. But in 1988 when he was coaching the Bears he suffered a heart attack.

When he was contacted by Pompei after his stroke, Ditka said, “I feel good right now and it’s not a big deal.”

As reported, Ditka spends his time doing broadcast work for ESPN, tending to his restaurant Ditka’s on East Chestnut in the Tremont Hotel, making appearances and playing golf.

Ditka will not fulfill his ESPN duties from Bristol, Conn., this weekend, the network said.

After he suffered his heart attack at 49, he was back in the office eight days later and back on the sidelines in 11 days against doctor’s orders.

At the time, Ditka said he was “embarrassed” by the heart attack, and he reflected on his mortality.
“I don’t know what I experienced,” he said at the time. “I think I almost experienced embarrassment. It kind of was embarrassing that it happened to me. I mean, how could this ever happen to me?

I’ve highlighted above in red some of the classic warning signs for stroke as well as some of the typical excuses especially men give in regards to dealing with serious health issues like heart attacks and stroke.

Mike Ditka had two classic warning signs when he had his recent stroke but you should know them all, so here’s a review:

The most common stroke symptoms are:

  • Sudden numbness or weakness of face, arm or leg, especially on one side of the body
  • Sudden confusion, trouble speaking or understanding
  • Sudden trouble seeing in one or both eyes
  • Sudden trouble walking, dizziness, loss of balance or coordination
  • Sudden severe headache with no known cause

If you see someone having these symptoms or experience any of these symptoms yourself, call 911 immediately.   Treatment can be more effective if given quickly. Every minute counts.  So once again guys, don’t be a Ditka, take stroke seriously!

by David Dansereau for Know-Stroke.org

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David Dansereau at Know-Stroke.org