Dive Brief:
- Ablation with Abbott’s dual-energy catheter, the TactiFlex Duo, was safe and effective in treating atrial fibrillation patients after one year, study results showed.
- The device combines pulsed field ablation, or PFA, and radiofrequency energy in one catheter to give physicians more flexibility in complex cases of AFib, an irregular heart rhythm that can lead to stroke or heart failure.
- Data from the FlexPulse IDE study, presented at the European Society of Cardiology Congress last week and published in the journal EP Europace, is the basis for Abbott’s Food and Drug Administration submission to market TactiFlex Duo in the U.S. The catheter received Europe’s CE mark earlier this year.
Dive Insight:
The U.S. introduction of TactiFlex Duo is one of several key product launches that Abbott CEO Robert Ford has said to expect from the company over the next 12 months, along with the Amulet 360 left atrial appendage device, Libre Duo glucose-ketone sensor and a coronary intravascular lithotripsy system.
Abbott is battling with Boston Scientific, Medtronic and Johnson & Johnson for market share in electrophysiology, where newer PFA systems that use electrical pulses to treat AFib have seen strong demand. PFA limits the risk of injury to surrounding organs, compared with standard RF ablation, which delivers heat to scar heart tissue to block abnormal electrical signals that cause AFib.
Abbott also sells the Volt PFA system. On a July earnings call, Ford said the company launched a next-generation version of the Volt PFA catheter, known as Volt 2.0, in the U.S. in May. Expectations are high for Volt and TactiFlex Duo, which are both gaining strong traction in Europe, the CEO said.
By offering both PFA and RF energy, TactiFlex Duo is designed to help physicians tailor treatment to the patient's needs, according to Abbott.
In the FlexPulse IDE study, pulmonary vein isolation was successful in all 180 participants with paroxysmal AFib. The study met its primary effectiveness endpoint, with 74.6% of patients remaining free from documented arrhythmias, medication changes or repeat procedures, Abbott said. The primary safety endpoint event rate was 1.7%
The one-year results follow the presentation of six-month data from the study showing a strong safety and efficacy profile at the Heart Rhythm Society meeting in April.
