Claimed to be the world’s first six-lead personal ECG device, the US FDA had approved KardiaMobile 6L in May last year
US-based medical device firm AliveCor has announced that its six-lead electrocardiogram (ECG), known as KardiaMobile 6L, is now allowed for use to measure QTc and detect QT prolongation in COVID-19 (coronavirus) patients.
According to AliveCor, a prolonged QTc can cause potentially deadly side effect of drug-induced sudden cardiac death (DI-SCD) that is linked with the use of various medicines now being employed to treat coronavirus in patients.
The QTc is a heart rate corrected interval that reflects the integrity of the heart’s electrical recharging system.
The announcement follows guidance from the US FDA to help expand the availability of non-invasive remote monitoring devices during the COVID-19 pandemic.
AliveCor CEO Priya Abani said: “At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. The benefits of remote, personal ECG measurement have never been clearer.
“We are thankful to the FDA for issuing timely guidance to help expand the availability of our device to assist in the treatment of COVID-19 during this global health emergency.”
The company noted that more than 100 FDA-approved medications may prolong the QT interval.
Affected patients face a greater risk of a potentially dangerous arrhythmia called Torsades de Pointes, which can lead to sudden cardiac arrest and SCD.
Currently, several drugs are being used off-label to treat COVID-19, such as Hydroxychloroquine and Azithromycin, which have the potential for unwanted QT prolongation and worse, DI-SCD.
Mayo Clinic’s Windland Smith Rice Genetic Heart Rhythm Clinic and Sudden Death Genomics Laboratory genetic cardiologist and director Michael Ackerman said: “AliveCor’s KardiaMobile 6L technology can play a key role in obtaining the patient’s QTc as a vital sign to help guide the rapid and safe use of these drugs.
“In addition, the patient’s QTc can be obtained without exposing ECG technicians to affected patients which helps to conserve personal protection equipment (PPE) and thereby expand the capacity of our strained medical resources. We are encouraged by the progress being made by regulatory authorities in allowing us to rapidly respond to the COVID crisis.”
The approval enables medical personnel to use KardiaMobile 6L to collect a six-lead ECG (Lead I, II, III, aVR, aVL, aV), use manual tools to calculate QT duration and then make assessments with respect to patient medication.
FDA approved AliveCor’s KardiaMobile 6L in May
Claimed to be the world’s first six-lead personal ECG device, the US FDA had approved KardiaMobile 6L in May last year.
According to AliveCor, the Kardiamobile 6L is the only personal ECG to provide data from lead II. This is unavailable from smartwatch-based ECGs.
As a result, doctors, nurses and other medical professionals will now have the power to monitor QTc in patients receiving lifesaving treatment for COVID-19 – both at the hospital and at home.