Vektor Medical Earns CE Mark for vMap Non-Invasive Arrhythmia Mapping

Vektor Medical has obtained CE mark approval for its vMap system, a non-invasive tool developed with artificial intelligence (AI) that converts standard 12-lead ECG data in 3D arrythmia source maps in less than a minute.

vMap aims to help physicians improve ablation outcomes for patient with arrhythmias like atrial fibrillation (AFib) and ventricular tachycardia. According to the company, using the tool has been related to reduction in total procedure time.

The technology offers a quick, non-invasive method to spot potential drivers of arrhythmia and guide treatment. It’s designed to complement existing lab technologies and provides a scalable solution that fits into clinical workflows, the company said.

The EU approval milestone comes as the commercialization and adoption of pulsed field ablation (PFA) are quickly accelerating. vMap can boost PFA’s impact by giving electrophysiologists fast, iterative insights into the best ablation targets during pre-procedure planning and in the EP lab.

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Dr. Lucas Boersma, an electrophysiologist at St. Antonius Hospital Nieuwegein said EP labs in Europe need cost-effective ways to improve ablation outcomes, especially when patients have more complex forms of AFib.

“vMap is emerging as a simple, non-invasive way to gain critical insights upfront and during procedures, supporting more efficient workflows and informed decision-making,” Dr. Boersma told the press. “By helping clinicians target arrhythmia sources more accurately and optimizing lab time, it has potential to improve outcomes whilst also enhancing the impact of other new approaches like pulsed field ablation. It’s exciting to see this technology now available in Europe.”

In July, Vektor enrolled the first patients in its U.S.-based IMPRoVED-AF clinical study of vMap. The study is designed to rigorously compare clinical outcomes in patients undergoing pulmonary vein isolation (PVI) alone versus PVI and additional driver ablation guided by vMap.

“vMap has shown its impact in the U.S. as a meaningful advancement in arrhythmia care,” said Rob Krummen, CEO of Vektor Medical. “Securing CE Mark under the EU Medical Device Regulation, one of the most rigorous regulatory frameworks in the world, underscores the strength of our technology and quality systems. With regulatory approvals now in place in the U.S. and Europe, we’re well positioned to accelerate adoption and expand access to this innovation globally.”