2023-02-04| Trials & Approvals

Abbott’s New Technologies for Arrhythmia Treatment Secure FDA and European Approval

by Richard Chau
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In a press release issued on February 2, Abbott Laboratories announced two latest approvals for its expanding portfolio of electrophysiology products targeting cardiac arrhythmia.

Abbott’s TactiFlex™ Ablation Catheter, Sensor Enabled™ is the world’s only ablation catheter with a flexible electrode tip and contact force sensing ability for treating people with abnormal heart rhythms (cardiac arrhythmia) such as atrial fibrillation (AFib). According to the press release, the device successfully obtained a CE Mark, meaning that it complies with the relevant EU legislation and is allowed to be sold within the European Economic Area (EEA). 

Also, the company’s FlexAbility™ Ablation Catheter, Sensor Enabled™ recently secured an expanded indication by the U.S. Food and Drug Administration (FDA) for treating patients with a complex heart condition known as ventricular tachycardia (VT) in patients with non-ischemic cardiomyopathy (NICM).

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CE-marked Catheter Brings Good News to Arrhythmia Patients

AFib occurs when the heart’s chambers are out of sync, causing them to beat too rapidly. This may lead to blood clots in the heart, which in turn increases the risk of stroke and heart failure. It is the most common type of arrhythmia affecting 37 million people worldwide (and millions of patients in Europe).  

Such condition (as well as other types of arrhythmia) can be treated by ablation, in which long flexible catheters are first inserted into the heart, followed by the delivery of radiofrequency (RF) energy through the catheters to disrupt the cardiac tissues responsible for the abnormal heart rhythm. Abbott’s TactiFlex is the world’s first ablation catheter with a flexible tip and contact force sensor. It is also proven to reduce procedure time and radiation exposure for patients. When integrated with the company’s EnSite X EP System, the device allows physicians to accurately identify areas in the heart requiring ablation. 

Given the CE Mark, the device is now available for use in Europe, Africa, Japan, and Australia. In addition, it is currently undergoing FDA review for pre-market approval. 

Expanded Indication for Product Treating Potentially Fatal Heart Condition

NICM is a type of heart muscle disease that compromises the heart’s ability to pump blood effectively. This is typically associated with VT, an abnormally fast heart rate that may lead to potential heart failure or cardiac arrest if not treated. Treatment procedures for these patients are considered complex because of the nature of the disease itself and the need to treat both the inside and outside surfaces of the heart. Abbott received FDA approval for an expanded indication of its FlexAbility, a flexible tip ablation catheter that helps physicians to identify abnormal signals and treat VT in patients with NICM.

According to the company’s LESS-VT study, the first FDA-approved pre-market trial on ablation for treating VT of NICM origin, 80% of study patients treated with the device were free from VT for at least six months after they were treated. The data also showed statistically significant improvements in patients’ mental and physical quality-of-life measures.

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