Physicians can perform an ablation to treat arrhythmias, in which long flexible tools—called catheters—are inserted into the heart to study and treat the arrhythmia. The catheters deliver radiofrequency (RF) energy to disrupt the tissue in the heart responsible for creating the abnormal heart rhythm.
Abbott’s TactiFlex catheter uses a tip design with a laser-cut pattern that flexes when in contact with the heart wall to direct irrigation flow to the treated tissue7 and to increase catheter stability by up to two-times for consistent therapy delivery5.
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The catheter generated strong clinical outcomes in the TactiFlex AF IDE study for its treatment using high-power ablation (between 40 and 50 Watts)8. The study showed the catheter created fast, safe lesions to treat the patient’s arrhythmia the first time with over 99% acute procedural success3.
Abbott’s TactiFlex catheter is now available in Europe, Africa, Japan and Australia. It is currently undergoing FDA review for pre-market approval.
NEW U.S. EXPANDED INDICATION FOR CATHETER DESIGNED TO TREAT COMPLEX HEART CONDITION
The company also received FDA approval for an expanded indication of its FlexAbility Ablation Catheter™, Sensor Enabled™ (SE), a flexible tip catheter that helps physicians identify abnormal signals and apply therapy to treat a complex heart condition known as ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy (NICM). NICM is a type of heart muscle disease that prevents the heart from pumping blood effectively. This is associated with VT, a fast heart rhythm that can lead to cardiac arrest if untreated. Procedures to treat these patients are considered complex due to the nature of the disease itself and the need to treat both inside and outside surfaces of the heart.
Abbott’s LESS-VT study was the first FDA-approved pre-market trial to study the safety and effectiveness of ablation for the treatment of VT with NICM origin. Once treated with the FlexAbility Ablation Catheter, SE, 80% of study patients were free from VT for at least six months post-procedure9. The data also showed statistically significant improvements in patients’ mental and physical quality-of-life measures9.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.
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