MUNICH, Germany — "It's a revolution because it provides information no one has ever seen before from any other cardiac imaging modality," said Torsten Krümmel, CEO and founder of BMDSys (Jena, Germany).
A refreshing change of pace, talking with a German engineer after days spent with marketing directors touring the cardiac imaging exhibitions in the München Messe during the annual congress of the European Society of Cardiology (ESC; Sophia Antipolis, France).
Krümmel was demonstrating the Apollo CXS, an innovation in electrophysiological diagnosis that uses magnetic field imaging (MFI) to pick up the faint signals of muscle activity of the heart to display changes to muscles generated during all phases of the heartbeat.
"It can answer the question as to whether you need an implanted defibrillator or not," said Krümmel.
"At the moment there is no tool that with reasonable speed and at a reasonable cost can distinguish who is going to be part of the 465,000 people in the U.S. alone who die each year of sudden cardiac death," he said.
"There are no biomarkers identified for this condition, and the only theoretical possibility involves poking around in the heart with a wire to provoke ventricular tachycardia (V-tach ), which is long, expensive and quite dangerous, and therefore cannot be considered for screening," he said.
MFI provides this tool and cardiologists are desperate to solve this problem, he said, noting the number of seminars and presentations at ESC each day devoted to sudden cardiac death.
In risk stratification for sudden cardiac death, the guidelines from both the American Heart Association (AHA; Dallas) and European Society of Cardiology suggest that if a patient demonstrates an ejection fraction below 35% of maximum, then the patient should receive an implantable cardioverter-defibrillator (ICD).
"The problem is that in the group below 35% there are people who do not need an ICD, while in the group above 35% there remain many people who have a high risk for sudden cardiac death," Krümmel said.
Which explains, he said, why 80% of the people receiving an ICD do not need one, "though this practice is medically justified for the thousands of people who do need one and whose lives are saved by them."
MFI provides a first-ever diagnosis of heart muscle function that can identify with high sensitivity and specificity those patients like to need an ICD, he said.
The Apollo CXS features an array of 55 superconducting quantum interference devices (SQUID), extremely sensitive magnetometers used to measure extremely small magnetic fields, such as subtle changes in the human body.
SQUIDs are being used as an alternative to traditional sensors for magnetic resonance imaging (MRI) to create high sensitivity for certain applications.
"To give you an idea of the sensitivity, if you turned one of these sensors toward the moon and someone switched on the ignition of a lunar vehicle, that signal would be picked up by the SQUID," said Krümmel the engineer.
The signal of heart muscle is 10 million times weaker than the magnetic field of the earth picked up by compass needles, he explained, and the Apollo CXS is sold with special shielding fitted to a dedicated room at a clinic.
This explains why the first investor in BMDSys when it started up in 2005 was Imedco (Hägendorf, Switzerland), a designer and manufacturer of custom radio frequency and magnetic shieldings for MRI equipment.
The company installed its first operational MFI in 2007 at the University of Jena Hospital after receiving the CE mark earlier that year.
After sudden cardiac death screenings, a second application for the Apollo CXS is for diagnosis of ischemia in traditional stress-and-rest testing.
"Electrocardiograms (ECGs) do not provide the depth of data as MFI," said Krümmel, because the electronic signal must pass through body tissue and then through the resistance of the skin, resulting in a lot of artifacts.
"The heart has loops of electrical currents inside cardiac muscles that do not travel to the electrode on the skin for ECG," he said.
These muscle signals are captured by MFI providing a rich detail from 55 individual readings that can be assembled to provide great specificity, sensitivity and accuracy for diagnosis.
A third major application for the Apollo CXS is acute ischemia, as MFI can identify patients with acute MI though they present normal ECG readings and test negative for the troponin biomarker.
Everyday applications for the Apollo CXS in a clinic include follow-up monitoring after bypass surgery or percutaneous intervention procedures, localization of ectopic pathways, cardiac diagnosis for pregnant women and fetal cardiac diagnostic.
Apollo CXS is non-invasive and contact-free, hovering just a few inches above the patient and covering an 11" diameter of the chest with its sensor array.
The imaging workstation displays heart function in ECG-like graphs, though there are 55 potential readings from every heartbeat, showing areas of concern with precision.
Morphological data from other imaging modalities such as ultrasound, computed tomography or MRI, can be integrated into the Apollo CXS workstation.
The unit can be fitted to the ceiling of any room at least 10 feet high and it weighs a ton, or more exactly just under eight tons, thanks to the cooling system needed for the SQUIDs.
In the 18 months since receiving the CE approval, BMDSys won some early home market sales with Charité Hospital in Berlin, St. Georg Hospital in Hamburg, and a private cardiology clinic in Darmstadt.
A university in New York state has ordered one, as well as St. George University (London).
"We also have an order from China and expect another sale in Munich, said Krümmel the CEO.
"We are well satisfied with progress and consider that we are already halfway toward our goals with the current orders," he added.
He said there is one competitor, CardioMag Imaging (Schenectady, New York) that uses the SQUID technology, "but they only apply the technology to acute ischemia for chest pain clinics, which is 10% of our targeted markets."
The CMI device uses nine detectors compared to the 55 used in Apollo CXS, Krümmel said, "and it is easier to install because they do not shield the acquisition room. But if a truck drives past the data is spoiled, which you would not learn until after the patient has left."
Privately held, BMDSys attracted a €1.5 million ($2.1 million) investment from the Free State of Thuringia and subsequent funding from venture capital firms KfW Bankengruppe (Frankfurt am Main, Germany), IBG (Beteiligungsgesellschaft Sachsen-Anhalt mbH; Magdeburg, Germany) and the Munich-based arm of Wellington Partners.