Abbott Announces Regulatory Decisions for a Pair of Arrhythmia Devices

Article

On February 2, Abbott announced their FlexAbility™ Ablation Catheter, Sensor Enabled had received an expanded approval from the US Food and Drug Administration and their TactiFlex™ Ablation Catheter, Sensor Enabled received a CE Mark.

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Abbott is touting the expansion of their foothold in arrhythmia with the announcement of regulatory approvals in the US and Europe for their FlexAbility™ Ablation Catheter, Sensor Enabled and the TactiFlex™ Ablation Catheter, Sensor Enabled.

Announced in a statement on February 2, Abbott pointed out their TactiFlex Ablation Catheter, Sensor Enabled received a CE Mark from the European Marketing Agency for treating patients with common arrhythmias and the FlexAbility Ablation Catheter, Sensor Enabled had received an approval from the US Food and Drug Administration (FDA) for an expanded indication to include treatment of ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy (NICM).1

"When we treat complex ablation cases for people battling arrhythmias, we want to eliminate the arrhythmia and get our patients back to living their lives," said Isabel Deisenhofer, MD, professor, head of the department of Electrophysiology at the German Heart Centre Munich in Germany. "The TactiFlex catheter’s data around using high-power during ablation will be game-changing for patients. When you combine these tools with Abbott’s EnSite X EP System, the innovation is truly opening new doors in patient care."

Billed by Abbott as the world’s first ablation catheter designed with a unique flexible tip and contact force sensing, with a proven ability to reduce procedure times and patients’ exposure to radiation, the TactiFlex Ablation Catheter, Sensor Enabled can be integrated with the company’s EnSite X EP System to allow physical to accurate identify areas in the heart requiring ablation. With the CE Mark, the device is now available for use in Europe, Africa, Japan, and Australia. In their statement, Abbott pointed out the TactiFlex™ Ablation Catheter, Sensor Enabled is currently under review by the FDA for premarket approval.

The expanded indication for the FlexAbility Ablation Catheter, Sensor Enabled is based on the results of the LESS-VT study, which was a first FDA-approved premarket trial to study the safety and effectiveness of ablation for the treatment of VT with NICM origin. Results of the study suggested 80% of patients were free from VT for at least six months post-procedure after treatment with the FlexAbility Ablation Catheter, Sensor Enabled, with data also indicting statistically significant improvements in patients’ mental and physical quality of life measures.

The FDA points out the FlexAbility Ablation Catheter, Sensor Enabled should not be used in patients with active systemic infections, tumors, or clots in the heart, those with recent heart surgery, those with prosthetic valves, and those unable to receive heparin or an acceptable anti-clotting alternative.2

References

  1. Abbott announces U.S. and European approvals for new technologies to support effective treatment for abnormal heart rhythms. Abbott MediaRoom. https://abbott.mediaroom.com/2023-02-02-Abbott-Announces-US-and-European-Approvals-for-New-Technologies-to-Support-Effective-Treatment-for-Abnormal-Heart-Rhythms. Published February 2, 2023. Accessed February 2, 2023.
  2. Center for Devices and Radiological Health. FlexAbility ablation catheter, sensor enabled – p110016/S080. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/recently-approved-devices/flexability-ablation-catheter-sensor-enabled-p110016s080. Accessed February 2, 2023.

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