UK medtech company Creavo Medical Technologies has launched a trial of its mobile magnetocardiography (MCG) device at five US research facilities: Mayo Clinic, Baylor University, Vanderbilt University, University of Cincinnati and Wake Forest University. The trial will enrol approximately 720 patients, making it the largest MCG trial to take place in the United States, and is scheduled to be completed by mid-2019.
Creavo’s cardiac diagnostic device is designed to help physicians rule out active ischemia in patients presenting to the emergency department (ED) with chest pain. It can be used at a patient’s bedside to measure and report electromagnetic fluctuations caused by heart activity.
Each year, eight to 10 million patients complaining of chest pain present to an ED in the USA. “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 EDs,” explains Gregory J Fermann from the University of Cincinnati. “This device has the potential to become an essential tool in the rapid evaluation of these patients.”
“On behalf of the entire MAGNET ACS-US investigative team, I am excited to report that we are open to recruitment of ED patients,” adds Fermann, who serves as the US Chief Investigator for the MAGNET ACS-US trial.
“Our device has the potential to tackle a global unmet need,” says Creavo’s CEO Steve Parker. “Non-ischemic chest pain patients place a huge strain on EDs, 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.”
Portable MCG rapidly diagnoses heart disease
Following extensive research into the use of MCG in UK emergency departments, Parker says that the company is pleased to be taking this research further afield into the US.
“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,” explains Ben Varcoe, chief scientific officer at Creavo. “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.”
Creavo’s MCG device received CE mark registration in Europe in November 2016 and secured 510(k) clearance as a device that measures and displays magnetic signals generated by the heart from the US FDA in October 2017.