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news.Endosense, a medical technology company focused on efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has selected Datatrak for its first two studies in the Efficas study series.
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According Endosense, the Efficas studies are intended to demonstrate that the use of contact force control during cardiac ablation utilizing its TactiCath force-sensing catheter results in superior outcomes as compared to ablations performed without a force sensor. Outcomes data from the Efficas I and II studies will help in the design of future Efficas studies with clinical endpoints.
Hendrik Lambert, vice-president of clinical affairs and regulatory at Endosense, said: “The Efficas study data will be a very important addition to Endosense’s large and growing scientific armamentarium proving the comparative value of contact force-sensing in the catheter ablation treatment of cardiac arrhythmias, and it is critical that the data be well documented and managed from day one.”
Laurence Birch, chairman of the board at Datatrak, said: “Endosense’s decision to invest in Datatrak ONE early in the clinical development of the Efficas studies will yield lower trial costs throughout the life of the pipeline. We applaud Endosense’s decision to choose our unified technology platform.”