Endosense announced on 6 May 2009 that it has received 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 of the right atrium.
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 17 very experienced investigators at eight European centres. During procedures on 42 enrolled supraventricular tachycardia 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 Dr Karl-Heinz Kuck, 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 reconduction 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, 13-16 May.
Endosense plans to release the TactiCath system in Europe in the second half of 2009.