Boston Scientific has obtained an approval in Europe for the latest addition to its pulsed field ablation portfolio, with the Farapoint focal catheter.
The CE mark brings a new indication to the company’s burgeoning Farapulse platform for irregular heart rhythms, adding the treatment of right atrial flutter and the delivery of ablation to the cavotricuspid isthmus area of the cardiac muscle.
Pulsed field ablation systems have made waves in the treatment of atrial fibrillation, including Boston Scientific’s Farapulse, which logged more than $1 billion in sales during its first year on the U.S. market.
And this past summer, the platform received FDA approval that basically doubles its reach in the treatable afib population, adding people with a persistent arrhythmia lasting longer than a week to its initial indication covering more intermittent cases of afib.
Compared to the company’s initial Farawave catheters—which can form 3D basket and flower shapes to help isolate arrhythmia-causing signals from the heart’s pulmonary veins, as well as the posterior wall—Farapoint is designed to deliver focal and linear ablations, allowing clinicians to draw more precise lesions across the tissue while connected to a heart-mapping tool.
Earlier this year, Boston Scientific put forward a clinical study showing that nearly all patients who received Farapoint ablations to the cavotricuspid isthmus—the portion of the right atrium bridging the inferior vena cava and the tricuspid valve—saw no recurrence of their atrial flutter within one year, and about on par with standard thermal radiofrequency ablation.
The trial, titled Advantage-AF, also included patients with afib and atrial tachycardia, as a person may have multiple types of arrhythmias at the same time, causing shortness of breath, chest tightness and fatigue.
The company previously stated that it expected to receive an FDA approval for Farapoint by the end of this year, as well.
Meanwhile, Boston Scientific has also been developing its next-generation pulsed field ablation catheter—Faraflex, which expands into a ringed, sphere-like structure with integrated heart mapping capabilities—and announced that the device completed its first human procedures earlier this year. Its launch is slated for 2027.