A new cardiac diagnostic device (Vitalscan) aimed at helping physicians rule out active ischaemia in patients presenting to the emergency department with chest pain is being trialled at five of the most respected research facilities in the USA—Mayo Clinic, Baylor University, Vanderbilt University, University of Cincinnati, and University, Winston-Salem. The device, developed by Creavo, is a mobile medical magnetometer that is designed to be used at a patient’s bedside to measure and report electromagnetic fluctuations caused by heart activity.
Approximately 720 patients will be enrolled throughout the trial, which is the largest magnetocardiography (MCG) trial ever to take place in the USA and is scheduled to be completed by mid-2019.
Gregory J Fermann (University of Cincinnati), US chief investigator for the MAGNET ACS-US, comments: “Each year, 8 to 10 million patients complaining of chest pain present to an emergency department 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 Emergency Departments. This device has the potential to become an essential tool in the rapid evaluation of these patients.”
Steve Parker, CEO at Creavo states: “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.
According to a press release, there have been several notable achievements for Creavo in the last two years. The 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. Following initial funding, the company raised £13.4m ($17m) in private equity funding in July 2017. The round was oversubscribed and exceeded Creavo’s funding target, reflecting strong investor support and endorsement of the company’s strategy and team.