Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has announced that it has received the CE mark for its TactiCath system. The first force-sensing ablation catheter developed worldwide, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure. The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium.
“The CE mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrythmias,” said Eric Le Royer, president and chief executive officer of Endosense. “With its unique ability to measure contact force, we expect the TactiCath to have a major positive impact on the safety and efficacy of catheter ablation, while also standardizing ablation techniques and decreasing the learning curve.”
The CE mark for TactiCath was granted based on select data submitted from Endosense’s TOCCATA (TOuCh+ for CATheter Ablation) clinical study, which was performed by seventeen very experienced investigators at eight European centers. During procedures on forty-two enrolled SVT patients, the device was found to cause no serious adverse events, and the primary study endpoint was reached.
“The availability of the TactiCath marks an important advance in the field of catheter ablation,” said Karl-Heinz Kuck, M.D. (Asklepios Klinik St. Georg, Hamburg, Germany), Endosense European Scientific Advisor and primary investigator of the TOCCATA trial. “The TactiCath is a critically important addition to our treatment armamentarium, as it will help to prevent perforation and identify sites of low contact force which may lead to re-conduction from the pulmonary veins in patients undergoing atrial fibrillation ablation.”
Acute data from the TOCCATA study will be presented at the Heart Rhythm Society’s 30th Annual Scientific Sessions in Boston, May 13 – 16.
Endosense plans to release the TactiCath system in Europe in the second half of 2009.