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  • I'm going to discuss with you three of my inventions

  • that can have an effect on 10 to a 100 million people,

  • which we will hope to see happen.

  • We discussed, in the prior film, some of the old things that we did,

  • like stents and insulin pumps for the diabetic.

  • And I'd like to talk very briefly about three new inventions

  • that will change the lives of many people.

  • At the present time, it takes an average of three hours

  • after the first symptoms of a heart attack are recognized by the patient,

  • before that patient arrives at an emergency room.

  • And people with silent ischemia --

  • which, translated into English, means they don't have any symptoms --

  • it takes even longer for them to get to the hospital.

  • The AMI, Acute Myocardial Infarction,

  • which is a doctor's big word so they can charge you more money --

  • (Laughter)

  • -- means a heart attack. Annual incidence: 1.2 million Americans.

  • Mortality: 300,000 people dying each year.

  • About half of them, 600,000, have permanent damage to their heart

  • that will cause them to have very bad problems later on.

  • Thus 900,000 people either have died

  • or have significant damage to their heart muscle.

  • Symptoms are often denied by the patient, particularly us men,

  • because we are very brave. We are very brave,

  • and we don't want to admit that I'm having a hell of a chest pain.

  • Then, approximately 25 percent of all patients never have any symptoms.

  • What are we going to do about them? How can we save their lives?

  • It's particularly true of diabetics and elderly women.

  • Well, what is needed for the earliest possible warning of a heart attack?

  • A means to determine if there's a complete blockage of a coronary artery.

  • That, ladies and gentlemen, is a heart attack.

  • The means consist of noting something a little technical,

  • ST segment elevation of the electrogram --

  • translated into English, that means that

  • if there's an electrical signal in the heart, and one part of the ECG --

  • which we call the ST segment -- elevates,

  • that is a sure sign of a heart attack.

  • And if we had a computer put into the body of a person who's at risk,

  • we could know, before they even have symptoms,

  • that they're having a heart attack, to save their life.

  • Well, the doctor can program a level of this ST elevation voltage

  • that will trigger an emergency alarm,

  • vibration like your cell phone, but right by your clavicle bone.

  • And when it goes beep, beep, beep, you better do something about it,

  • because if you want to live you have to get to some medical treatment.

  • So we have to try these devices out

  • because the FDA won't just let us use them on people

  • unless we try it out first,

  • and the best model for this happens to be pigs.

  • And what we tried with the pig was external electrodes on the skin,

  • like you see in an emergency room,

  • and I'm going to show you why they don't work very well.

  • And then we put a lead, which is a wire, in the right ventricle inside the heart,

  • which does the electrogram, which is the signal voltage from inside the heart.

  • Well, with the pig, at the baseline,

  • before we blocked the pig's artery to simulate a heart attack, that was the signal.

  • After 43 seconds, even an expert couldn't tell the difference,

  • and after three minutes -- well,

  • if you really studied it, you'd see a difference.

  • But what happened when we looked inside the pig's heart, to the electrogram?

  • There was the baseline -- first of all, a much bigger and more reliable signal.

  • Second of all, I'll bet even you people who are untrained can see the difference,

  • and we see here an ST segment elevation right after this sharp line.

  • Look at the difference there. It doesn't take much --

  • every layperson could see that difference,

  • and computers can be programmed to easily detect it.

  • Then, look at that after three minutes.

  • We see that the signal that's actually in the heart,

  • we can use it to tell people that they're having a heart attack

  • even before they have symptoms so we can save their life.

  • Then we tried it with my son, Dr. Tim Fischell,

  • we tried it on some human patients who had to have a stent put in.

  • Well, he kept the balloon filled to block the artery,

  • to simulate a blockage, which is what a heart attack is.

  • And it's not hard to see that -- the baseline

  • is the first picture on the upper left.

  • Next to it, at 30 seconds, you see this rise here,

  • then this rise -- that's the ST elevation.

  • And if we had a computer that could detect it,

  • we could tell you you're having a heart attack so early

  • it could save your life and prevent congestive heart failure.

  • And then he did it again. We filled the balloon again a few minutes later

  • and here you see, even after 10 seconds, a great rise in this piece,

  • which we can have computers inside, under your chest like a pacemaker,

  • with a wire into your heart like a pacemaker.

  • And computers don't go to sleep.

  • We have a little battery and on this little battery

  • that computer will run for five years without needing replacement.

  • What does the system look like?

  • Well, on the left is the IMD, which is Implantable Medical Device,

  • and tonight in the tent you can see it -- they've exhibited it.

  • It's about this big, the size of a pacemaker.

  • It's implanted with very conventional techniques.

  • And the EXD is an External Device that you can have on your night table.

  • It'll wake you up and tell you to get your tail to the emergency room

  • when the thing goes off because, if you don't, you're in deep doo-doo.

  • And then, finally, a programmer that will set the level of the stimulation,

  • which is the level which says you are having a heart attack.

  • The FDA says, OK, test this final device after it's built in some animal,

  • which we said is a pig, so we had to get this pig to have a heart attack.

  • And when you go to the farmyard, you can't easily get pigs to have heart attacks,

  • so we said, well, we're experts in stents.

  • Tonight you'll see some of our invented stents.

  • We said, so we'll put in a stent,

  • but we're not going to put in a stent that we'd put in people.

  • We're putting in a copper stent,

  • and this copper stent erodes the artery and causes heart attacks.

  • That's not very nice, but, after all, we had to find out what the answer is.

  • So we took two copper stents and we put it in the artery of this pig,

  • and let me show you the result that's very gratifying

  • as far as people who have heart disease are concerned.

  • So there it was, Thursday morning we stopped the pig's medication

  • and there is his electrogram, the signal from inside the pig's heart

  • coming out by radio telemetry.

  • Then, on Friday at 6:43, he began to get certain signs,

  • which later we had the pig run around --

  • I'm not going to go into this early stage.

  • But look what happened at 10:06 after we removed this pig's medication

  • that kept him from having a heart attack.

  • Any one of you now is an expert on ST elevation. Can you see it there?

  • Can you see it in the picture after the big rise of the QRS -- you see ST elevation?

  • This pig at 10:06 was having a heart attack.

  • What happens after you have the heart attack, this blockage?

  • Your rhythm becomes irregular, and that's what happened 45 minutes later.

  • Then, ventricular fibrillation, the heart quivers instead of beats --

  • this is just before death of the pig -- and then the pig died; it went flat-line.

  • But we had a little bit over an hour where we could've saved this pig's life.

  • Well, because of the FDA, we didn't save the pig's life,

  • because we need to do this type of animal research for humans.

  • But when it comes to the sake of a human, we can save their life.

  • We can save the lives of people who are at high risk for a heart attack.

  • What is the response to acute myocardial infarction, a heart attack, today?

  • Well, you feel some chest pain or indigestion.

  • It's not all that bad; you decide not to do anything.

  • Several hours pass and it gets worse, and even the man won't ignore it.

  • Finally, you go to the emergency room.

  • You wait as burns and other critical patients are treated,

  • because 75 percent of the patients who go to an emergency room with chest pains

  • don't have AMI, so you're not taken very seriously.

  • They finally see you. It takes more time

  • to get your electrocardiogram on your skin and diagnose it,

  • and it's hard to do because they don't have the baseline data,

  • which the computer we put in you gets.

  • Finally, if you're lucky, you are treated in three or four hours after the incident,

  • but the heart muscle has died.

  • And that is the typical treatment in the advanced world -- not Africa --

  • that's the typical treatment in the advanced world today.

  • So we developed the AngelMed Guardian System

  • and we have a device inside this patient, called the Implanted AngelMed Guardian.

  • And when you have a blockage, the alarm goes off

  • and it sends the alarm and the electrogram to an external device,

  • which gets your baseline electrogram from 24 hours ago

  • and the one that caused the alarm, so you can take it to the emergency room

  • and show them, and say, take care of me right away.

  • Then it goes to a network operations center,

  • where they get your data from your patient database

  • that's been put in at some central location, say, in the United States.

  • Then it goes to a diagnostic center, and within one minute of your heart attack,

  • your signal appears on the screen of a computer

  • and the computer analyzes what your problem is.

  • And the person who's there, the medical practitioner, calls you --

  • this is also a cell phone -- and says,

  • "Mr. Smith, you're in deep doo-doo; you have a problem.

  • We've called the ambulance. The ambulance is on the way.

  • It'll pick you up, and then we're going to call your doctor, tell him about it.

  • We're going to send him the signal that we have, that says you have a heart attack,

  • and we're going to send the signal to the hospital

  • and we're going to have it analyzed there,

  • and there you're going to be with your doctor

  • and you'll be taken care of so you won't die of a heart attack."

  • That's the first invention that I wanted to describe.

  • (Applause)

  • And now I want to talk about something entirely different.

  • At first I didn't think migraine headaches were a big problem

  • because I'd never had a migraine headache,

  • but then I spoke to some people who have three or four every week of their life,

  • and their lives are being totally ruined by it.

  • We have a mission statement for our company doing migraine, which is,

  • "Prevent or ameliorate migraine headaches

  • by the application of a safe, controlled magnetic pulse

  • applied, as needed, by the patient."

  • Now, you're probably very few physicists here.

  • If you're a physicist you'd know there's a certain Faraday's Law,

  • which says if I apply a magnetic pulse on salt water --

  • that's your brains by the way --

  • it'll generate electric currents, and the electric current in the brain

  • can erase a migraine headache.

  • That's what we have discovered.

  • So here's a picture of what we're doing.

  • The patients who have a migraine preceded by an aura

  • have a band of excited neurons -- that's shown in red --

  • that moves at three to five millimeters a minute towards the mid-brain.

  • And when it hits the mid-brain, that's when the headache begins.

  • There's this migraine that is preceded by a visual aura,

  • and this visual aura, by the way -- and I'll show you a picture --

  • but it sort of begins with little dancing lights,

  • gets bigger and bigger until it fills your whole visual field.

  • And what we tried was this; here is a device called the Cadwell Model MES10.

  • Weighs about 70 pounds, has a wire about an inch in diameter.

  • And here's one of the patients who has an aura

  • and always has a headache, bad one, after the aura. What do we do?

  • This is what an aura looks like.

  • It's sort of funny dancing lights, shown there on the left and right side.

  • And that's a fully developed visual aura, as we see on top.

  • In the middle, our experimentalist, the neurologist, who said,

  • "I'm going to move this down a little and I'm going to erase half your aura."

  • And, by God, the neurologist did erase it, and that's the middle picture:

  • half of the aura erased by a short magnetic pulse.

  • What does that mean?

  • That means that the magnetic pulse is generating an electric current

  • that's interfering with the erroneous electrical activity in the brain.

  • And finally he says, "OK, now I'm going to -- "

  • all of the aura get erased with an appropriately placed magnetic pulse.

  • What is the result? We designed a magnetic depolarizer

  • that looks like this, that you could have -- a lady, in her pocket book --

  • and when you get an aura you can try it and see how it works.

  • Well, the next thing they have to show is what was on ABC News,

  • Channel 7, last week in New York City, in the 11 o'clock news.

  • Anchor: For anyone who suffers from migraine headaches --

  • and there are 30 million Americans who do -- tonight: a possible answer.

  • Eyewitness news reporter Stacy Sager tonight, with a small and portable machine

  • that literally zaps your migraines away.

  • Christina Sidebottom: Well, my first reaction was that it was --

  • looked awfully gun-like, and it was very strange.

  • Stacy Sager: But for Christina Sidebottom, almost anything was worth trying

  • if it could stop a migraine.

  • It may look silly or even frightening as you walk around with it in your purse,

  • but researchers here in Ohio organizing clinical trials for this migraine zapper,

  • say it is scientifically sound --

  • that, in fact, when the average person gets a migraine,

  • it's caused by something similar to an electrical impulse.