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Abbott receives CE Mark for the TactiFlex™ Duo Ablation Catheter to treat patients with abnormal heart rhythms

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Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, is designed with dual-energy to treat at...

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Abbott's TactiFlex Duo Ablation Catheter has received CE Mark approval in Europe, enhancing its portfolio for treating atrial fibrillation. This innovative catheter delivers dual-energy solutions, which could significantly improve treatment outcomes for patients facing complex arrhythmia challenges, positioning Abbott favorably in a growing market segment.

Sentiment Rationale

The CE Mark approval is a significant positive catalyst, reflecting potential revenue growth. Historical examples include previous FDA approvals that boosted stock prices for similar healthcare advancements.

Trading Thesis

ABT is positioned for growth following the TactiFlex Duo approval; LT bullish.

Market-Moving

  • Abbott's TactiFlex Duo Catheter's approval opens new revenue opportunities in Europe.
  • Growing AFib patient population heightens demand for effective treatment solutions.
  • Advancements in Abbott's PFA technologies reinforce its competitive market position.
  • Successful commercial cases post-approval may boost investor confidence.

Key Facts

  • Abbott's TactiFlex Duo Catheter receives CE Mark approval in Europe.
  • It treats atrial fibrillation with dual radiofrequency and pulsed field ablation.
  • TactiFlex Duo enhances Abbott's PFA portfolio, following recent Volt PFA System approvals.
  • AFib affects 8 million Europeans over 65; expected to double by 2055.
  • The CE Mark was supported by data from Abbott's FOCALFLEX CE trial.

Companies Mentioned

  • Abbott (ABT): Abbott's new catheter strengthens its foothold in electrophysiology.

Corporate Developments

This news fits within 'Corporate Developments' as it showcases Abbott's innovative product advancement in the medical device space, crucially enhancing its competitive edge in atrial fibrillation treatment.

Abbott Receives CE Mark for TactiFlex™ Duo Ablation Catheter to Combat Abnormal Heart Rhythms

Abbott (NYSE: ABT) has announced the receipt of the CE Mark in Europe for its advanced TactiFlex™ Duo Ablation Catheter, which is designed to treat patients suffering from atrial fibrillation (AFib). With this new approval, the first successful commercial applications of the TactiFlex Duo have already been executed in the European Union.

Innovative Dual-Energy Technology for Cardiac Ablation

The TactiFlex Duo Ablation Catheter represents a significant advancement in Abbott's pulsed field ablation (PFA) technology portfolio. This innovative device is capable of delivering both radiofrequency energy and pulsed field ablation energy, enabling healthcare providers to precisely target and treat irregular heart rhythms. This dual-energy approach is particularly beneficial for addressing challenging cases of AFib.

In a cardiac ablation procedure, the quality of the lesions created is crucial for stopping the source of arrhythmia. TactiFlex Duo is engineered to provide tailored therapy lesions to improve the overall efficacy of treatment.

Supporting Data and Clinical Efficacy

The CE Mark approval for the TactiFlex Duo was bolstered by findings from Abbott's FOCALFLEX CE Mark study, a global clinical trial encompassing sites in the European Union, the United Kingdom, and Australia. Preliminary results indicated that TactiFlex Duo safely and effectively treats patients with AFib.

  • Approximately 8 million Europeans aged 65 and older currently live with AFib, a figure projected to double over the next 30 years.
  • AFib increases risks of stroke, heart failure, and mortality, making effective treatment essential.

“A successful cardiac ablation is critical for patients who do not respond to medication,” stated Prof. Isabel Deisenhofer, M.D., head of the Electrophysiology department at the German Heart Center Munich. “TactiFlex Duo allows for a seamless switch between treatment options during procedures, tailored to each patient's unique needs and anatomy.”

Integration with Abbott's Technology Suite

The TactiFlex Duo Ablation Catheter works in conjunction with Abbott's EnSite™ X EP System, which generates detailed three-dimensional maps of the heart. This integration allows doctors to better locate and treat the sources of arrhythmia, thereby enhancing procedural safety and effectiveness.

Progress in Abbott's Electrophysiology Portfolio

The approval of TactiFlex Duo marks the third major advancement in Abbott's electrophysiology portfolio within a year. Following this, the company’s Volt PFA System also received FDA and CE Mark approvals.

“The TactiFlex Duo Catheter adds a sophisticated tool to Abbott’s growing PFA portfolio, specifically for complex cases such as co-existing heart diseases and patients with a history of failed ablations,” said Christopher Piorkowski, M.D., Chief Medical Officer of Abbott’s electrophysiology division.

Future Trials and Breakthrough Designation

Enrollment for Abbott's FLEXPULSE IDE trial, aimed at evaluating TactiFlex Duo for AFib treatment in the United States, was concluded last year. In a significant development, the FDA provided Breakthrough Device Designation to TactiFlex Duo for treating ventricular tachycardia (VT) using PFA in October 2025. This designation recognizes the product's potential to address unmet medical needs in treating life-threatening arrhythmias.

About Abbott

Abbott is a leading global healthcare company dedicated to helping individuals live fuller lives at all stages. Its extensive portfolio includes innovative diagnostics, medical devices, nutritionals, and branded generic medicines, supported by over 114,000 employees serving people in more than 160 countries.

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