Following approval, the company also reported the first commercial cases using the catheter in Europe, completed this week. Dr. Isabel Deisenhofer, head of the department of Electrophysiology at the German Heart Center Munich, became one of the first to use TactiFlex Duo after its approval.
TactiFlex Duo represents Abbott’s latest advancement within its pulsed field ablation (PFA) portfolio. The medtech giant designed the system to deliver tailored therapy lesions in two ways. Its radiofrequency energy capabilities use heat to destroy tissue responsible for erratic heart signals. The pulsed field function uses high-energy electrical pulses to destroy the cells causing abnormal heart rhythms. This can reduce the risk of damaging adjacent tissue in patients with complex disease or anatomy.
The catheter also has FDA breakthrough device designation for the treatment of ventricular tachycardia (VT). It could rival J&J MedTech’s ThermoCool dual-ablation catheter. Abbott’s Electrophysiology business continues to make inroads in ablation technology, with the company’s Volt PFA system earning FDA approval for treating AFib last month.
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Abbott supported its CE mark approval with data from its FOCALFLEX CE mark study. The global clinical trial, conducted across Europe, the UK and Australia, showed that TactiFlex Duo demonstrated clinically meaningful performance in the safety and effectiveness of treating patients with AFib.
TactiFlex Duo integrates with Abbott’s EnSite X EP system. EnSite X EP, a heart-mapping system, helps physicians visualize and position tools such as catheters within the heart. It builds on the catheter’s previous-generation flexible electrode tip and contact force sensing to now include PFA energy delivery. Abbott says this enables more effective and safer procedures.
The company also continues to evaluate TactiFlex Duo for AFib in the U.S., completing enrollment in its FLEXPULSE FDA investigational device exemption (IDE) study last year.
Commentary from Abbott officials and physicians using TactiFlex Duo
Dr. Christopher Piorkowski, chief medical officer of Abbott’s Electrophysiology business, said:
“The TactiFlex Duo Catheter provides another advanced tool to Abbott’s growing PFA portfolio for treating patients with more complex cases such as those with co-existing heart disease and heart failure, long-lasting AFib, ventricular arrhythmias and patients with a history of failed ablations. By focusing on a holistic view of patient care, physicians now have multiple clinically proven tools to enhance workflow and to effectively treat a wide range of arrhythmias.”
Dr. Isabel Deisenhofer, head of the department of Electrophysiology at the German Heart Center Munich, and one of the first physicians to use TactiFlex Duo following CE mark approval, said:
“TactiFlex Duo’s most unique feature is its dual options that allow physicians to seamlessly switch treatment during a procedure based on the patient’s personalized needs and anatomy. For patients who do not respond to medication and other traditional treatments, a successful cardiac ablation is critical as it can reduce the risk of recurrence of AFib and provide long-lasting relief.”
Dr. John Silberbauer, electrophysiologist at the Sussex Cardiac Centre in Brighton, UK, who conducted cases in the FOCALFLEX study, said:
“AFib is a progressive disease that becomes harder to treat over time, and there is not a one-size-fits-all approach, which makes long-term management complex. TactiFlex Duo allows me to safely tailor each ablation treatment to the patient’s anatomy, and results show that it consistently improves symptoms and quality of life for many.”
