UK based medical device company launches largest US study of its kind
A new cardiac device developed by UK-based medical technology company Creavo is currently part of the largest US study of its kind.
The company’s diagnostic device is designed to help physicians rule out active ischemia in patients who go to the emergency department (ED) with chest pain. The device – currently being trialled at five research facilities in the US – is a mobile medical magnetometer which can be used at a patient’s bedside to measure and report electromagnetic fluctuations caused by heart activity.
The trial is set to include approximately 720 patients and is scheduled to be completed by the middle of 2019.
Approximately 720 patients will be enrolled throughout the trial, which is the largest magnetocardiography (MCG) trial ever to take place in the United States and is scheduled to be completed by mid-2019.
Professor Gregory J. Fermann, executive vice chairman and director of the Clinical Trials Centre at the University of Cincinnati, one of the institutions trialling the device, said: “Each year, 8 to 10 million patients complaining of chest pain present to an emergency department (ED) in the United States”.
“The ability to quickly risk stratify and safely discharge ED patients presenting with symptoms consistent with chest pain of cardiac origin is critically important to the overall flow of patients through crowded Emergency Departments. This device has the potential to become an essential tool in the rapid evaluation of these patients.”
Steve Parker, chief executive officer at Creavo said: “Our device has the potential to tackle a global unmet need. Non-ischemic chest pain patients place a huge strain on emergency departments as the current rule-out triage process of electrocardiograms and blood biomarker tests can take a number of hours. Our device is designed to rapidly aid physicians with the decision to rule out acute coronary syndrome by performing a non-invasive five-minute scan, freeing up resources and bed space.
“We’ve conducted extensive research into the use of MCG in UK emergency departments and are pleased to be taking our research further afield into the US.”
Commenting on the technology behind the device, professor Ben Varcoe, chief scientific officer at Creavo said: “MCG technology has been used in medical research since the 1960s, but historically it has been restricted to larger immobile SQUID devices which aren’t practical for emergency medical settings. Our device can be deployed directly at the patient’s bedside and uses MCG to detect abnormal patterns in the magnetic fields of the heart.”