Sunday, February 23, 2014

A digital device in pivotal trials listens for the sound of a potential heart attack in the making

by Deanna Pogorelc,

February 18th 2014 4:07 PM

For Marie Johnson, coming up with a better way to detect coronary artery disease is both a business and a personal mission.

Johnson is CEO of AUM Cardiovascular, a Minnesota medical device company that’s developing a potentially cheaper, simpler, eight-minute test to detect signs of coronary artery disease — the primary cause of heart attack.

In a clinical study under way, the company is putting its Cadence device head-to-head against nuclear stress testing with the hope of showing that it’s just as effective at detecting obstructive coronary artery disease. If it can show that, Johnson expects to be able to launch the device in Europe in the second half of this year and in the U.S. next fall.

Johnson lost her 41-year-old husband to an unexpected heart attack in 2009. Although he was seemingly healthy, the autopsy revealed that several of his coronary arteries were blocked and that a plaque had ruptured in the left anterior descending vessel of his heart. Blockage in this vessel, nicknamed “the widowmaker,” is particularly associated with mortality.

Coincidentally, at the time, Johnson had been working with 3M scientists to develop a computerized stethoscope as part of her PhD program and had used the prototype device to collect hundreds of data points from the sound of her husband’s heart just a few months before.

That served as a launching pad for Johnson to begin developing a system comprising sensors and algorithms that could identify a certain acoustic signature associated with blockage of the coronary arteries. A small acoustic device about the size of an egg is pressed against a few different points on the chest. It uses sensors to listen for turbulence in blood flow through coronary vessels that suggest they could be blocked.

“The device is pretty simple – there are some advanced algorithms associated with noise and signal capture, but the real juice is in the algorithm where we analyze the data to provide the doctor with a reading of normal, diseased or inconclusive,” Johnson said.

When plaque buildup on the inner walls of the arteries reaches a certain point, patients may become a candidate for some kind of intervention to prevent worsening of the disease and heart attack. Johnson said AUM’s test can’t tell doctors exactly which vessel the blockage is in, but can give them an indication of whether further interrogation is warranted.

For the pivotal trial that’s going on now, the company is collecting data from 729 patients who present in one of 15 sites with chest pain and also have two or more coronary risk factors. They’re being tested with AUM’s device and with a nuclear stress test, a method of imaging that shows how blood is flowing into the heart.

“We can’t do everything that a nuclear stress test can do, but what we’re saying is that we’re not inferior in detecting obstructive coronary artery disease,” Johnson said.

A nuclear stress test costs on average somewhere around $1,000, Johnson explained, involves the use of a radiopharmaceutical and can take up to three hours. AUM’s device, she said, would have a price point around $200 per test and would deliver results in about eight minutes.

Data collection for the trial should wrap up by December, Johnson said, with a filing for FDA clearance likely to follow around this time next year, if all goes well. But first, AUM will tackle commercialization in Europe. Johnson expects the device to get CE Mark by July and launch in 10 centers in Europe by the end of the year.

She said the company, which was formed in 2009 and now has six full-time staffers, will be raising a round of funding to support the European launch soon.

Copyright 2014 MedCity News.

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