FDA Approves Vektor Medical vMap ECG Mapping System for Identifying Potential Arrhythmia Sources

November 9, 2021—Vektor Medical, Inc. announced that it has received FDA 510(k) clearance for vMap, the company’s computational electrocardiogram (ECG) mapping system. With this clearance, the vMap system will be commercially available in the United States.

According to the company, vMap maps potential arrhythmia sources (or hot spots) associated with stable or unstable arrhythmias throughout the heart to improve outcomes in ablation procedures.

In < 3 minutes, the operator can input case information, download and markup an ECG, and receive a three-dimensional, interactive arrhythmia map visualizing the inside and outside of the heart. With a map available in minutes, Vektor Medical Chief Executive Officer Mike Monko explained that physicians are able to create an effective ablation plan and spend less time finding target locations.

The system, which has successfully identified a wide variety of arrhythmia sources, including atrial fibrillation, can be used noninvasively as a standalone tool or complementary with traditional invasive electroanatomic mapping systems.

“Traditional arrhythmia mapping techniques are labor and time-intensive, and 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,” commented Amir Schricker, MD, in the company’s announcement. “To shorten procedure times and improve ablation success, electrophysiologists need to be able to visualize arrhythmia hot spots in the heart quickly and accurately.

“Our clinical experience with vMap has been incredibly positive. Using noninvasive ECG data, the system is extremely simple and fast to use and quickly provides a hot spot map so we know where to target our efforts without having to navigate the whole heart or order additional imaging.” Dr. Schricker is Medical Director of Cardiac Electrophysiology at Mills-Peninsula Medical Center, a Sutter Health hospital, in Burlingame, California.

According to Mr. Monko, the goal of vMap is to increase first-pass success rates, lower risk, and decrease ablation’s cost burden on the health care system.