Abbott's Volt PFA System Gets CE Mark To Treat Patients With Abnormal Heart Rhythms

Abbott Laboratories

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(RTTNews) - Abbott (ABT) Thursday announced it has received CE Mark in Europe for the Volt PFA System to treat patients battling atrial fibrillation (AFib).

With the earlier-than-expected CE Mark, Abbott has begun commercial PFA cases in the EU with physicians who have already gained experience with the Volt PFA System within Abbott's PFA clinical studies.

The company said it will further expand use of Volt in EU markets throughout the second half of the year.

About 8 million Europeans over the age of 65 are living with AFib, a number expected to double over the next 30 years. People living with AFib face an increased risk of stroke, heart failure and death, and many rely on cardiac ablation to treat the condition effectively.

CE Mark approval for the Volt PFA System was granted based on strong results from Abbott's Volt CE Mark study, a clinical trial conducted at centers in Europe and Australia.

"The launch of Abbott's Volt PFA system marks a major milestone in the evolution of electrophysiology across Europe and signals we're moving beyond early therapy approaches to new systems that incorporate key physician feedback and clinical insights to optimize PFA therapy," said Prof. Puererfellner. "PFA is significantly changing our approach to treating patients and it's exciting to see the Volt PFA System build on the therapy's potential and bring new benefits to clinical teams so we can improve the lives of more patients battling conditions like AFib."