Cardiac catheter ablation is commonly used to treat rhythm disorders, but physicians have been forced to estimate the level of contact force required. Too little may render the procedure ineffective and too great a force may perforate the heart wall.
Endosense (Geneva, Switzerland) has just launched a first-in-human study of its TactiCath force-sensing catheter that will guide physicians so that they can use optimal contact force for the appropriate lesion creation in a catheter ablation procedure.
"We believe this procedure may allow the standardization of this technique and enable 6 million patients around the world to benefit from the therapy who are just waiting for the right technology to expand," President/CEO Eric Le Royer, told Medical Device Daily. "It's our proprietary technology and clearly physicians are interested. We know that we'll be the pioneers."
Endosense has launched the TOCCATA (TOuCh+ for CATheter Ablation) clinical study to evaluate the safety of TactiCath. The 70-patient European multi-center safety study is designed to gain CE-mark approval for the treatment of atrial arrhythmias. Secondary endpoints were designed to evaluate the value of force-sensing in successfully impacting outcomes of the ablation procedure.
The TactiCath is an 8.5 Fr sheath-compatible, open-irrigated, steerable catheter that integrates Endosense's Touch+ fiber-optic sensor technology at the catheter tip.
Prior to the launch of this study, 11 patients have been treated sthus far by different investigators, including Endosense European scientific advisors Karl-Heinz Kuck, MD, at St. Georg Hospital (Hamburg, Germany) Dipen Shah, MD, University Hospital of Geneva (Switzerland) and Nadir Saoudi, MD, at Princess Grace Hospital (Monaco). Those patients had different arrhythmia pathologies, including atrial fibrillation.
Le Royer said that all of the patients were treated successfully, giving the company momentum to push forward with the TOCCATA study.
Catheters have been used for years to deliver radiofrequency energy to create a scar or ablation line which electrically isolates the partially damaged heart muscle from the surrounding healthy muscle, preventing abnormal electrical signals. TactiCath simply refines the technique, giving physicians a real-time, objective measure of contact force during the procedure.
"Trying to navigate in the 3-D cavity is a quite a challenge in a beating heart, to assess if the right force is being used," Le Royer said. "If too much force is used, a perforation may occur. If there's not enough force, you may do a superficial lesion or the wrong one. It's a balancing act between act between excessive and insufficient force."
Assuming a positive outcome from this safety study, Endosense will immediately proceed with commercialization plans in Europe, and then consider starting trials in the U.S., seeking FDA clearance via a PMA.
Endosense is a venture capital-funded company with no major partnerships. But Le Royer told MDD that as TactiCath moves forward in the development cycle, future partnerships with med-tech companies are "an option" he'll consider.