FDA clears ECG mapping system that tracks arrhythmia hot spots
Vektor Medical has received FDA clearance for its electrocardiogram (ECG) mapping system designed to examine potential "hot spots" in the heart associated with stable or unstable arrhythmias. The solution, vMap, explores the patient's heart in less than three minutes and was built with ablation patients in mind.
When using vMap, a clinician receives a 3-D map that includes a visualization of the inside and outside of the heart. The solution can be used on its own or alongside more traditional mapping systems, and it builds its maps without the use of CT or MRI imaging results.
“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. To shorten procedure times and improve ablation success, electrophysiologists need to be able to visualize arrhythmia hot spots in the heart quickly and accurately,” Amir Schricker, MD, MS, medical director of cardiac electrophysiology at Mills Peninsula Medical Center in Burlingame, California, said in a prepared statement. “Our clinical experience with vMap has been incredibly positive. Using non-invasive 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.”
“Cardiac arrhythmias impact millions of people across the globe, increasing the 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,“ added Mike Monko, Vektor Medical CEO. “With vMap we are changing how electrophysiologists think about mapping. By providing a hot spot map in only minutes based on non-invasive ECG data, 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."