Thursday, April 26, 2018 3:42:06 PM
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the Heartsentry demonstrated a strong correlation to ultrasound results in initial studies with 50 patients. More significantly, Willis said, it demonstrated 500 percent sensitivity over ultrasound, consistently higher accuracy and much lower variability.
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University of California San Francisco cardiologist Geoff Tison was at the center of those early studies,
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This time, Tison will oversee a research team testing the Heartsentry’s ability to diagnose the arterial condition of 150 volunteers at Diablo Clinical Research Inc. in Walnut Creek, Calif.
Now let's analyze this. Geoff Tison was already involved with the initial testing with 50 patients. Not 5 or 10 BUT 50 patients and the results were EXCELLENT. A strong correlation with the very expensive and labor intensive ultrasound results. Now Geoff Tison is involved with testing 150 patients. Do you think the 150 are going to produce different results than the 50?? Not at all. But very likely the 150 are going to show the same strong correlation as the 50. So this shouldn't surprise anyone when the news comes out saying this. Now think about it: do you think the FDA Is going to fail to give approval to this device that can warn millions of people years ahead that you need to make some changes here to avoid heart problems? Of course not. They will most certainly give approval. Think about this. Blood pressures are a everyday procedure at doctors offices around the world. So the HeartSentry device can be incorporated so easily into the everyday practice of doctors without any drastic change to their routine. Now instead of just heart rate and blood pressure readings, now they get one more very crucial piece of data indicating the health of their vessels. Even if HeartSentry wasn't quite as accurate as ultrasound techniques, still the FDA would approve of it. They know typical blood pressure devices are not perfectly accurate but they are still very useful for diagnosing the health of their patients. Similarly, HeartSentry does not have to be perfectly accurate for FDA to give approval. The FDA is interested in everyone's health. And big insurance companies have another interest. Some of the biggest payouts they have to make for medical travel insurance is someone having a heart attack or stroke and needing major surgery or care. They would love to know if someone is a higher risk. And charge accordingly. And we should want to know so we can make lifestyle changes NOW before we have a heart attack or stroke. It is obvious this will get FDA Approval. Just relax and but at these levels and make sure to thank the sellers for the generous gift.
Outwardly identical to a standard blood pressure cuff, the Heartsentry demonstrated a strong correlation to ultrasound results in initial studies with 50 patients. More significantly, Willis said, it demonstrated 500 percent sensitivity over ultrasound, consistently higher accuracy and much lower variability.
Filling a gap
University of California San Francisco cardiologist Geoff Tison was at the center of those early studies, mentored by the Heartsentry’s inventor Jonathan Maltz who went on to help found Lexington Biosciences.
” This measure for endothelial function is something physicians have long wanted to be able to do easily. . . So physicians should be encouraged that they finally have a simple tool that really anybody can use.”
— Eric Willis, President, Lexington Biosciences Inc.
This time, Tison will oversee a research team testing the Heartsentry’s ability to diagnose the arterial condition of 150 volunteers at Diablo Clinical Research Inc. in Walnut Creek, Calif.
“Generally, we really don’t measure endothelial function for cardiovascular risk stratification even though the more savvy cardiologists understand endothelial function correlates with risk,” Tison told BioWorld MedTech. “The reason is there’s no easy and reliable way to do that.”
Tison’s job: to see if he can match the measurement results historically obtained through large and very costly ultrasound by using the simpler, less expensive Heartsentry. Do that, he said, and the next goal could be to measu
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