SAN DIEGO--(BUSINESS WIRE)--Vektor Medical, the developer of the world’s first technology to rapidly map cardiac arrhythmias using only 12-lead ECG data, today announced Circulation: Arrhythmia and Electrophysiology has published a peer-reviewed manuscript of the clinical data from a study evaluating the accuracy of its vMap® technology. The system, which was cleared by the U.S. Food and Drug Administration in November 2021, demonstrated high accuracy for vMap in identifying arrhythmia sources throughout the heart.
The mapping system uses the information found in a 12-lead ECG and provides physicians with accurate and actionable insights to treat cardiac arrhythmias. The easy-to-use and non-invasive technology aims to improve first-pass ablation success, lower risks from invasive mapping and long fluoroscopy exposure, and reduce procedure times, all of which are expected to reduce healthcare costs associated with ablation.
The article titled “Forward-Solution Noninvasive Computational Arrhythmia Mapping: The VMAP Study” was authored by researchers and cardiologists at the Department of Medicine at the University of California San Diego, Veterans Affairs San Diego Healthcare System, Mills Peninsula Medical Center, Medical University of South Carolina, Katherine Kacena Consulting, Technomics Research, the Department of Bioengineering at the University of California San Diego, and Vektor Medical, Inc.
The blinded, multicenter, independently-adjudicated study compared the accuracy of vMap in identifying source locations of seven atrial and ventricular arrhythmias, as well as atrial and ventricular pacing to arrhythmia sources identified during the invasive electrophysiology study. System accuracy exceeded pre-specified performance goals in the primary and secondary endpoints:
- Regional accuracy for ventricular tachycardia (VT) and premature ventricular complexes (PVC) without structural heart disease and ventricular scar burden <10% (primary endpoint) was 98.7% (74/75 cases, 95% CI: 96.0 - 100%, p<0.001 to reject predefined null hypothesis).
- For all enrolled cases (which includes atrial and ventricular fibrillation), regional accuracy (secondary endpoint 1) was 96.9% (247/255 cases, 95% CI: 94.7 - 99.0%, p<0.001 to reject predefined null hypothesis).
- Accuracy for all enrolled cases in identifying the exact or neighboring segments (secondary endpoint 2) was 97.3% (248/255 cases, 95% CI: 95.2-99.3%, p<0.001 to reject predefined null hypothesis).
- Center-to-center absolute spatial accuracy across all arrhythmia subgroups was 15 mm [Interquartile range: 7–25 mm].
- The median analysis time from ECG data upload into the system and ending with display of the mapping results was 0.8 minutes (IQR: 0.4–1.4 minutes).
“Results of the vMap study surpassed our expectations and serve as further evidence of vMap’s potential to improve ablation success, reduce risk, and shorten procedure time,” said David Krummen, M.D., FACC, FHRS, co-founder and inventor of Vektor Medical. “We have created this technology with the goal of positively impacting millions of people suffering from cardiac arrhythmias.”
Traditional arrhythmia mapping is often labor- and time-intensive, frequently requiring fluoroscopy for intracardiac navigation. vMap aims to improve first-pass ablation success, lower risks from invasive mapping and fluoroscopy exposure, and reduce procedure times. The system may also be used to guide stereotactic ablative radiotherapy for refractory ventricular arrhythmias. These features together are expected to improve arrhythmia care and reduce healthcare costs associated with targeted arrhythmia therapy.
The abstract from Vektor’s clinical validation study was presented by Dr. David Krummen at Heart Rhythm 2022. The company is currently rolling out the technology at select cardiovascular centers across the country.
About vMap
vMap is designed to quickly, easily, and non-invasively map arrhythmia sources associated with focal- or fibrillation- type arrhythmias in all cardiac chambers, septum, and outflow tracts. The easy-to-use system takes less than three minutes for a clinician to input case information, upload and markup an ECG, and receive a 3D interactive arrhythmia source location map visualizing the inside and outside of the heart.
About Vektor Medical
San Diego-based Vektor Medical, Inc. is the developer of the world’s first FDA-cleared forward-solution arrhythmia mapping technology to rapidly identify arrhythmia source locations using only 12-lead ECG data. This data is analyzed using proprietary computational modeling to create actionable 2D and 3D cardiac arrhythmia source probability maps. The company’s advanced, non-invasive cardiac arrhythmia mapping platform aims to improve the care of cardiac arrhythmias worldwide.
