Dive Brief:
- Abbott received Europe’s CE mark for a dual-ablation catheter used to treat a common heart arrhythmia, the company said Tuesday.
- The TactiFlex Duo catheter can deliver both radiofrequency and pulsed field ablation energy to create scars that stop irregular heart rhythms. Physicians can switch between treatments during a procedure based on a patient’s needs and anatomy, Isabel Deisenhofer, head of the department of electrophysiology at the German Heart Center Munich, said in a statement from Abbott.
- The device is the latest in Abbott’s portfolio of pulsed field ablation technologies, a fast-growing segment that is becoming increasingly competitive as more companies introduce new products.
Dive Insight:
Atrial fibrillation, a heart condition characterized by a rapid, erratic heart rhythm, can be treated by a procedure using energy to create tiny scars that block the source of an arrhythmia. In the past, a common approach was to use radiofrequency energy, or heat, but PFA is a newer technology that instead uses high energy electrical pulses to scar tissue.
PFA is becoming more widely adopted by physicians due to its reduced risk of damaging adjacent tissue and shorter procedure times. Abbott introduced its first PFA device last year, the Volt PFA system, after competitors Medtronic, Boston Scientific and Johnson & Johnson had already brought their first products to the U.S. market. The Volt PFA system received Food and Drug Administration approval and a CE mark last year.
Abbott’s latest CE mark for its TactiFlex Duo system was based on a clinical trial conducted in the European Union, United Kingdom and Australia, that the company said demonstrated safety and effectiveness in treating patients with AFib.
Christopher Piorkowski, chief medical officer of Abbott’s electrophysiology business, said the device provides a tool for treating patients with more complex cases, such as people with co-existing heart disease and heart failure, long-lasting AFib, ventricular arrhythmias and a history of failed ablations.
In the U.S., Abbott received the FDA’s breakthrough device designation last year for the use of PFA to treat ventricular tachycardia, a fast heart rate that requires immediate attention as it can be life threatening.
The company finished enrolling in a clinical trial last year to evaluate its TactiFlex Duo system for the treatment of AFib in the U.S.
