Biotronik, a manufacturer of implantable cardiac devices, has released TactiCath catheter with contact force sensing ability. The TactiCath catheter, an Endosense company product, is an irrigated RF contact force ablation catheter offering an advance in ablation therapy for patients with cardiac arrhythmias and particularly atrial fibrillation (AF).
Biotronik had initiated the TactiCath launch with simultaneous cases at heart centers across Europe, including professor Richard Schilling at St Bartholomew’s Hospital, London UK, Dr Juergen Schreieck, University of Tuebingen and professor Dipen Shah, HUG Geneva.
The new TactiCath is the commercially available irrigated force-sensing RF ablation catheter that can provide physicians with objective measures of contact force reliably and in real-time. The technology has the potential to dramatically change clinical practice, and lead to improved efficacy, safety and reproducibility of catheter ablation procedures.
The TactiCath is a second generation device, with a solid scientific background established by the results of its preclinical and clinical research program. The Toccata clinical trial, upon which CE mark was granted, established safety and effective performance of the device and has shown that contact force varies from operator to operator and from ablation site to ablation site. It has raised the expectation that contact force technology has the potential to improve the outcome of AF ablation procedures.
Reportedly, beginning in May, Endosense’s Efficas study series will be initiated, with the intention to demonstrate that the use of contact force control during cardiac ablation utilising the TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed without force sensing.
Additionally, the ProForce registry will begin upon launch and will provide post-market surveillance with observational data of up to 2000 patients treated with the TactiCath catheter, and will study the use and impact of contact force monitoring during catheter ablation.
Marlou Janssen, global vice president of marketing and sales, said: “AF ablation is a key strategic focus of Biotronik. We have demonstrated our continued commitment to further build the EP franchise, by securing the exclusive distribution rights of the second generation TactiCath in all major markets outside the US, Japan and Asia.
“The TactiCath complements an already robust portfolio of ablation and diagnostic catheters, surrounded by comprehensive customer education and an International Fellows Program.”