TOCCATA Clinical Study - Multi-Center European Safety Study On Groundbreaking Technology For The Treatment Of Atrial Arrhythmias

Main Category: Heart Disease
Also Included In: Cardiovascular / Cardiology;  Clinical Trials / Drug Trials
Article Date: 08 Oct 2008 - 9:00 PDT

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Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac rhythm disorders, has launched the TOCCATA (TOuCh+ for CATheter Ablation) clinical study to evaluate the safety of the TactiCath™ system with enrollment gaining momentum. TOCCATA is a 70 patient European multi-center safety study. Constructed to gain the CE mark 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 start of this clinical trial marks the first use of the TactiCath force-sensing catheter in patients. Ten patients have been treated so far by different investigators including Endosense European Scientific Advisors Professor Karl-Heinz Kuck, M.D., at St. Georg Hospital in Hamburg, Germany, Professor Dipen Shah, M.D., at the University Hospital of Geneva, Switzerland and Professor Nadir Saoudi, M.D., at the Princess Grace Hospital, Monaco. The patients treated to date have had different arrhythmia pathologies, including atrial fibrillation.

"The first TOCCATA patients had their arrhythmia successfully treated at acute follow-up. The physicians' experiences have shown the tremendous potential of force-sensing to the clinical practice, and we're hopeful that the results will reinforce our initial findings," said Pr. Kuck, the principal investigator of TOCCATA.

With TactiCath, physicians can be assured they are using the optimal contact force for the appropriate lesion creation in a catheter ablation procedure. "Electro-physiologists have had to estimate - and frequently guess - the level of force required, as too little may render the procedure ineffective and too much may induce serious complications," said Pr. Shah. "The TactiCath has the potential to solve that." Pr. Shah was a key driver in the pre-clinical evaluation and validation of the product.

"The momentum we're experiencing in the TOCCATA trial is very exciting, and moves our company significantly toward the successful clinical evaluation and commercialization of our breakthrough TactiCath product," said Eric Le Royer, president and chief executive officer, Endosense. "The support and contributions of our Scientific Advisors have assisted us successfully through preclinical evaluations." Endosense's Scientific Advisory Board includes worldwide experts in the treatment of cardiac arrhythmias. In addition to Prs. Kuck, Saoudi, and Shah, other members include:

-- Warren Jackman, M.D., University of Oklahoma Health Sciences Center
-- Hiroshi Nakagawa, M.D., Ph.D., University of Oklahoma Health Sciences Center
-- Andrea Natale, M.D., Texas Cardiac Arrhythmias Institute
-- Vivek Reddy, M.D., University of Miami Hospital

Background on TactiCath

TactiCath is the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. It has the potential to impact safety and performance of the catheter ablation treatment of cardiac rhythm disorders, including atrial fibrillation (AF). AF is the most common cardiac rhythm disorder today, affecting more than six million people worldwide. Most AF patients are currently treated with ineffective and side effect-causing pharmaceutical drugs, with the primary alternative invasive ablation surgery. Endosense is focused on providing this sizeable patient population with a minimally invasive treatment option that is both safe and effective. This sizeable patient population represents a multi-billion-dollar market opportunity.

About Endosense

Founded in Geneva in 2003, Endosense is a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias. The company has pioneered the use of contact force measurement in catheter ablation, with the development of its proprietary Touch+™ sensor technology. Endosense's flagship product is the TactiCath™, the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. For more information, visit http://www.endosense.com.