I want to mention, dr.
Deepak chopra, that you have training in internal medicine and endocrinology.
How would you explain the creation of this particular device within the context of the medical community?
So, really, the technology was developed by a cardiac surgeon, and that cardiac surgeon was based out of new zealand and thought there had to be a safer way, a better way of managing late-day chart failure, and what we are talking about is class three heart failure.
What are the different classes?
There are four classes as designated by the new york heart association.
Classes one through four, and the most serious are one and effort you walk, and in the united states, you have about one million in class three, and over 250 thousand patients in class four.
What we are really talking about with class three, these are patients who cannot walk up a flight of stairs, they cannot go grocery shopping, they are afraid to have sex, and these are people that cannot even sleep on their back at night because there is so much congestion, so much blood backed up in the system.
Congestive heart failure.
So this would be the result of coronary artery disease, cardiomyopathy, many other things, hypertensive heart disease, where the blood backed up, so all of the blood that is coming to the heart backs up and gets congested in the lungs, so they cannot breathe, essentially, and what you have got is a mechanical device, i guess.
Are -- how does it work?
The device, we have a sample over there.
The device does basically two things.
When we are talking about congestive heart failure in class three, it is primarily in the left side of the heart or left ventricle, and that is a large percentage of the cases, and what we do is two things.
One, every time the balloon inflates along the ascending aorta, it plus -- presses blood down through the ascending and descending aorta to the rest of the body, and the reason why that is important, what we are doing during one phase of assistance is we are getting more oxygen to the heart or more energy to the heart to be able to function.
The second thing is we rapidly deflate the balloon.
As the left heart is starting to push blood or trying to push blood out, we deflate the balloon and create more or less a vacuum-like effect, which helps pull blood from the left heart, and what that does is it reduces the amount of work that the left heart has to do to get blood to the rest of the body, and really, what we are talking about here are the polls of muscles.
It requires the heart muscle to do less work but gives it more energy to function.
Now, is this available everywhere?
What is the status?
We have approval for the device in europe, but in the united states, we are in trial, so right now, we only have eight that have been activated to be able to enroll patients in the study, and that will grow significantly in the first part of the year, and on our website, we have something that people can click on to see if they qualify.
You have to do surgery to implant it?
The difference between this and the later stage devices is our devices can be put in through a small decision -- incision, so we make a small incision between the second and third rib, and you do not have to crack the breastbone and do a fully invasive procedure, and that reduces the amount of time.
How is it powered?
It is powered through an external battery stores, much like many of the pumps are today.
The biggest difference you see with this technology is it is outside the bloodstream.
So there are no other pumps that function outside the bloodstream, and the reason that is critical is patients do not have to go on blood thinning medications.
Injury inside, possibility of stroke tom a lots of risks with being inside.
As far as the medical community is concerned, we were talking about this idea of seeing things that other people don't. our doctors early adopters for something like this, or do they say, that is not the way we do it.
We are going to wait a long time . i think doctors will adopt it because there is nothing else right now for this kind of condition at this stage.
There is nothing else.
Either way, i do not know if you are familiar with it, but there are studies that show in stage one cardiac failure, yoga and breathing techniques improve output.
Well published studies.
So i think people should be aware of that.
I just adopted hot yoga.
I do not have hard yet output issues, but i have back issues.
There are mental techniques that allow you to regulate your heartbeat.
We teach them at our center in california, but they are also very early symptoms.
What role does the technology outside the body play?
For example, being able to track your heart, monitor it, find out if there is a problem with it, ask that may be available?
-- apps that might be available?
Cbs says they are not selling cigarettes, but what about monitoring a chronic situation?
There are technologies out there to measure some aspects.
There are sensors that are placed on the heart that tell the system went to inflate and deflate the balloon, but it does not monitor the patient situation.
Talking about technology is not about heart failure but monitoring heart activities.
I am wearing this watch right now.
You will see five sensors, and one of the sensors monitors heart rate.
Heart rate variability, which is the dance between the sympathetic and the parasympathetic nervous system, skin resistance, basal metabolic rate, and -- will we all be wearing those in five years?
Yes, because bio regulation is the next frontier through technology.
There are algorithms with all of these things that will even tell you how much you slept, how much time you slept in deep sleep, dreams phase, and even though it is not monitoring that, it is creating algorithms with other things.
Biotechnology that helps you monitor what is happening in your body is the frontier, and wireless technology can be picked up by an iphone or any handheld device, instantly transmit it to a supercomputer with instant interpretation, and what you might want to do to change or behavior.
That is it.
I want to thank you very much, dave rosa, chief executive of sunshine heart.
Keep us up-to-date as to when it becomes available in the united states.
Thank you very much.
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