Endosense Unveils TOCCATA Probation Results: The First Full Assessment Of Clout In Catheter Ablation
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Endosense has announced the proceeds of acute clinical results from the TOCCATA (TOuCh+ for CATheter Ablation) European clinical proof at Love Rhythm 2009, the Passion Rhythm Society's 30th Annual Scientific Sessions in Boston, May 13 - 16. The highly anticipated results of the 76-patient, multi-center interpret confirm the feasibility, safety and price of Endosense's TactiCath force-sensing ablation catheter during catheter ablation.
The first and alone force-sensing ablation catheter, TactiCath gives physicians a real-time, impersonal measure of contact exaction during the catheter ablation procedure. The TactiCath was granted the CE mark in May 2009.
The TOCCATA trial was designed to evaluate the safety and profit of force-sensing in the catheter ablation procedure. Conducted at eight centres in five countries, the recite was led by Principal Investigator Karl-Heinz Kuck, M.D. with knowledge from 20 additional highly experienced investigators. Enrolment in TOCCATA was completed in Feb 2009, with a complete of 76 patients (42 genuine SVT and 34 paroxysmal atrial fibrillation [AF]). Safety and treatment efficacy posses been proven for the SVT group, which has reached the peruse endpoints. Material from the AF group is anticipated by the point of May.
During the study, operators were accustomed full access to real-time effort hookup during catheter ablation but were blinded to force information during force assessment. Key findings, extracted from 185 hours of beef contact data, are the adult of two seperate Emotions Rhythm 2009 presentations by Dr. Kuck and TOCCATA investigator Dipen Shah, M.D.
These unique findings, based on the first comprehensive examination of the clinical knowledge among assorted very experienced operators, confirm the results of Endosense's extended pre-clinical testing of the TactiCath. Of note, TOCCATA investigators discovered:
- A particularly elevated variability of contact force practice across even genuine experienced operators, suggesting the critical need for an accurate and dependable object to degree contact vigour during the procedure;
- 12 percent of lesions created during the AF ablation procedure with a force of less than five grams, with half of these forces growth intermittent. This suggests that contact compel control may cure incision the approximate 30 percent re-intervention rate for AF catheter ablation; and
- A heavy character of cases in which transient forces worthier than 100 grams were exhibited during catheter manipulation. This is important, as pre-clinical studies keep indicated that the ability to prolong extra moderate levels of impact may divide the risk of complications.
"The early TOCCATA results are expressing for Endosense, as they validate our pre-clinical information and also clearly demonstrate the multitudinous important benefits of contact-force sensing during catheter ablation," said Eric Le Royer, head of the state and manager executive officer, Endosense. "The news also reinforces the TactiCath's prepatent to be the standard-setting technology solution for contact force measurement, stirring us closer to our goal of enabling the prevalent adoption of catheter ablation."
The two TOCCATA abstracts spotlight Endosense's continuous commitment to developing the clinical science last the TactiCath. Thanks to Heart Rhythm 2006, ten abstracts have been developed on the company's clinical research activities, based on the seminal work of Hiroshi Nakagawa, M.D., Ph.D. and Dr. Shah. This year, an supplementary abstract features the bearing of the concept of force-time integral in lesion characterization.
About Feelings Rhythm 2009
Heart Rhythm 2009 takes place May 13-16 at the Boston Exhibition and Business Center. The confab is the most comprehensive educational act on heart rhythm disorders, offering sorrounding 250 educational opportunities in multiple formats. The world's most renowned scientists and physicians testament even now a broad area of affection rhythm topics including cardiac resynchronization therapy, catheter ablation, cardiac pacing and heart failure as right as the advanced technology, including state-of-the-art pacemakers and defibrillators. http://www.HRSonline.org.
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