Biosense Webster receives CE mark approval for QDot Micro ablation catheter


Johnson & Johnson Medical Devices has today announced European CE mark approval of Biosense Webster’s QDot Micro radiofrequency (RF) ablation catheter.

According to a press release, the next-generation catheter that has demonstrated the ability to reduce total procedure time. This, the press release adds, is made possible by efficient and consistent lesion creation in conjunction with a simplified workflow.

Using the very high power QMode+, the QDot Micro is the first catheter to enable ablation at up to 90 watts of RF power for up to four seconds in a temperature-controlled ablation mode, significantly improving ablation efficiency without compromising safety, the press release notes.

QDot Micro is approved for use in Europe and Japan and is investigational only in the USA.

The current practice of RF ablation with irrigated catheters involves the delivery of moderate power (20–40 watts) for a relatively long duration (up to 20 seconds). QDot Micro with QMode+, enables ablation at up to 90 watts of RF power for four seconds or less, when using the nGEN generator.

In prospective, non-randomised trials, QDot Micro saved an average of 87 minutes per procedure and ablation with QDot Micro had up to 78% shorter mean fluoroscopy times in QMode+.

For patients, a shorter ablation time may require less anaesthesia and radiation and may result in less nursing and facility time. These time savings may also enable more procedures per day facilitating improved patient access, while reducing procedure costs by nearly €700 per procedure.

“Reducing procedure time and increasing efficiency are two key goals in treating arrhythmias, but very high-power ablation has previously been out of reach because of limited temperature sensitivity,” said Helmut Pürerfellner, Department of Cardiology, Elisabethinen Hospital, Linz, Austria. “With increased sensitivity and the ability to more accurately delineate between healthy tissue and scar tissue, QDot Micro brings effective technological solutions to these challenges and will make a significant difference for my patients by shortening procedure times.”

The first procedures with QDot Micro since receiving CE mark were successfully performed in St Jan Hospital, Bruges, Belgium, by Sebastien Knecht and Matthias Duytschaever; in OLV Hospital, Aalst, Belgium, by Tom De Potter, and in Elisabethinen Hospital, Linz, Austria, Helmut Pürerfellner and Martin Martinek.

“Biosense Webster is committed to partnering with physicians and innovating new technology that helps diagnose and treat cardiac arrhythmias,” said Uri Yaron, worldwide president of Biosense Webster. “With CE mark approval and the first procedures completed for QDot Micro, we are proud to help meet electrophysiologists’ needs for a higher power catheter with improved control that can safely, effectively, and efficiently restore patients’ heart rhythms.”

The catheter is integrated with the Carto 3 System, including Carto Smarttouch contact force technology and Visitag Surpoint.


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