vMAP™ Arrhythmia Hot Spot Detection System FDA Cleared

arrhythmia hot spot detection system

Vektor Medical, Inc. has gained U.S. FDA 510(k) clearance for its novel computational ECG mapping system, vMap™. The non-invasive technology requires no vests, CT or MRI imaging, or invasive mapping.

Background

Arrhythmia and its resolution is one of the bigger subjects addressed by device technologists over recent years, as our pages attest.

San Diego-based Vektor Medical, Inc. has developed the world’s first technology to rapidly map arrhythmias anywhere in the heart using only 12-lead ECG data. Proprietary computational modeling uses the data to create actionable 2D and 3D maps of potential arrhythmia sources. The company’s smart, simple, and non-invasive cardiac arrhythmia mapping platform aims to improve first-pass ablation success. This means lower risks from invasive mapping and long fluoro exposure, and reduce procedure times. In turn this offers the potential to reduce healthcare costs associated with ablation.

vMap screen displays arrhythmia hot spots, using data derived from 12 lead ECG
Vektor Medical vMap arrhythmia hot spot detection display

Newly FDA cleared, Vektor designed vMap to map potential arrhythmia sources (hot spots) associated with stable or unstable arrhythmias anywhere in the heart. This includes all four chambers, the septal wall, and the outflow tracts. It takes less than three minutes using only ECG data, to improve outcomes in ablation procedures.

With this clearance, the vMap system will now be made commercially available to sites across the U.S.

vMap has demonstrated success in identifying arrhythmia sources for a wide variety of arrhythmias, including atrial fibrillation. The easy-to-use system takes less than three minutes for a clinician to input case information, download and markup an ECG. The system delivers a three-dimensional, interactive arrhythmia hot spot map of the inside and outside of the heart. Clinicians can use vMap as a non-invasive standalone tool or as a complement to traditional invasive electro-anatomical mapping systems in planning and procedural settings. 

Clinician comments

“Traditional arrhythmia mapping techniques are labor-and time-intensive. Consequently physicians are only able to achieve complete success in a limited number of ablation procedures due to the lack of information on arrhythmia source locations. To shorten procedure times and improve ablation success, electrophysiologists need to be able to visualize arrhythmia hot spots in the heart quickly and accurately,” said Amir Schricker, MD, MS, Medical Director of Cardiac Electrophysiology at Mills Peninsula Medical Center, a Sutter Health hospital.

“Our clinical experience with vMap has been incredibly positive. Using non-invasive ECG data, the system is extremely simple and fast to use. Furthermore it quickly provides a hot spot map so we know where to target our efforts without having to navigate the whole heart. We can also avoid ordering additional imaging.”

Company comments

“Cardiac arrhythmias impact millions of people across the globe. The result is increased risk of serious health-related issues, such as stroke, heart failure, and even death. Yet, today’s therapies have significant issues. Drug therapy can have severe side effects and non-targeted ablation has disappointingly low success rates,“ said Vektor Medical CEO Mike Monko. 

“With vMap we are changing how electrophysiologists think about mapping. The system provides a hot spot map in only minutes based on non-invasive ECG data. With the information physicians can create a more effective ablation plan and spend less time finding target locations. Our goal is to increase first-pass success rates, lower risk, and decrease the current cost burden of ablation on the healthcare system.“

Source: Vektor Medical, Inc.

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