Michael Barbella, Managing Editor10.03.22
Vektor Medical Inc. is amassing further proof that its vMap technology can accurately identify heart arrhythmias.
Study data published in Circulation: Arrhythmia and Electrophysiology showed the vMap System's accuracy exceeded pre-specified performance goals in the primary and secondary endpoints:
The company is currently rolling out the technology at select cardiovascular centers throughout the United States.
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.
Cleared by the U.S. Food and Drug Administration (FDA) in November 2021, vMap 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. 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 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.
San Diego-based Vektor Medical Inc. developed 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.
Study data published in Circulation: Arrhythmia and Electrophysiology showed the vMap System's 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%, 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).
The company is currently rolling out the technology at select cardiovascular centers throughout the United States.
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.
Cleared by the U.S. Food and Drug Administration (FDA) in November 2021, vMap 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. 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 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.
San Diego-based Vektor Medical Inc. developed 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.