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J&J’s Biosense received CE Mark for QDOT MICRO ablation catheter

Biosense Webster, a subsidiary of Johnson & Johnson Medical Devices Companies, has received European CE mark approval for the QDOT MICRO radiofrequency (RF) ablation catheter.

QDOT MICRO treats symptomatic drug-refractory paroxysmal atrial fibrillation (AF). It has been designed to deliver high power ablation in a short amount of time.

The device is approved for use in Europe and Japan. It is still under investigation in the US.

Austria Elisabethinen Hospital Department of Cardiology professor Helmut Pürerfellner said: “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.

“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.”

Biosense Webster said that QDOT MICRO is a next-generation catheter and can deliver 90W of RF power in a four-second temperature-controlled catheter ablation session.

The catheter’s optimised temperature control and micro-electrode technology is designed to provide more efficient and consistent lesion creation with advanced diagnostics, while also simplifying the technique and reducing total ablation time.

Biosense Webster Worldwide president Uri Yaron said: “Biosense Webster is committed to partnering with physicians and innovating new technology that helps diagnose and treat cardiac arrhythmias.

“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.”

In February 2019, Biosense Webster started enrolling and treating patients in the US Investigational Device Exemption (IDE) study of QDOT MICRO.

The company commenced treatment in the European study of the device in May 2018.


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