Abbott Ablation Device Effective To Be Used For Artrial fibrillation For 1 Year
American global health care and medical device manufacturer, Abbott Laboratories, said it would use its study results to secure the US Federal Food and Drug Administration (FDA) approval for the TactiFlex Duo catheter that offers both pulsed field ablation (PFA) and RF energy for tailoring treatment of atrial fibrillation. Study showed that the ablation, which is the removal or destruction of body tissue, material, or surface layers through heat, cold, vaporisation, or other erosive methods, with Abbott’s dualenergy catheter, the TactiFlex Duo, is safe and effective in treating atrial fibrillation patients after one year.
The device combines 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 FDA submission to market TactiFlex Duo in the US, after receiving Europe’s CE mark, a mandatory conformity indicator that shows a product meets European Union health, safety, and environmental protection standards, earlier this year.
The US 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 glucoseketone 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 US in May.
Expectations are high for Volt and TactiFlex Duo, which are both gaining strong traction in Europe, the CEO said. By offering PFA and RF energy in one catheter, 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 percent of patients remaining free from documented arrhythmias, medication changes or repeat procedures, Abbott said. The primary safety endpoint event rate was 1.7 percent. 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.
