DATATRAK International, Inc. (OTCQX: DATA), a technology and services company focused on global eClinical solutions for the clinical trials industry, today announced that medical technology company Endosense has awarded DATATRAK the first two studies in the EFFICAS study series. The EFFICAS studies are intended to demonstrate that the use of contact force control during cardiac ablation utilizing Endosense's 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.
"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," said Hendrik Lambert, vice-president, clinical affairs and regulatory, Endosense. "We look forward to working with DATATRAK as we execute and report on these exciting studies."
"We are delighted that Endosense has entrusted DATATRAK with the first two studies in the EFFICAS series," said Laurence Birch, DATATRAK's Chairman of the Board. "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. While our competitors are striving to follow our lead in developing end-to-end solutions, DATATRAK is pushing the industry forward by driving clinical trial efficiencies."
Ablation may offer better outcomes than medication for ventricular tachycardia