St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results of the TOCCASTAR clinical trial at Heart Rhythm 2014, the Heart Rhythm Society’s 35 th Annual Scientific Sessions in San Francisco. Results from the first prospective, randomized study of contact-force ablation technology for the treatment of paroxysmal atrial fibrillation (AF) met primary endpoints and supplement the growing body of evidence that supports the safety and effectiveness of contact-force ablation technology. “The findings from the TOCCASTAR trial further demonstrate the strong safety and efficacy profile of the TactiCath irrigated ablation catheter for the treatment of atrial fibrillation,” said Dr. Vivek Reddy, director of electrophysiology at Mount Sinai Hospital, N.Y. “The results of this study have significant clinical relevance for optimal cardiac ablation therapy and provide compelling evidence that contact-force ablation procedures are effective in treating paroxysmal atrial fibrillation.” The TOCCASTAR study is a multicenter, non-inferiority study evaluating 300 patients in the U.S. and Europe. The investigational device exemption (IDE) clinical trial, which followed device performance and assessed patient outcomes through 12 months of follow-up, met its primary safety and effectiveness endpoints. Results demonstrated that the TactiCath™ Irrigated Ablation Catheter exceeded the safety and efficacy non-inferiority benchmarks set forth in the trial by 5.9 percent and 4.3 percent, respectively, based on a 95 percent confidence interval. In addition, approximately 75.9 percent of the patients that were treated optimally with contact-force ablation therapy via the TactiCath catheter were free from paroxysmal AF at the end of the 12 month follow-up period, compared to 58.1 percent of patients who did not receive 10 grams or more of force. Through previous studies, including TOCCATA, EFFICAS I and EFFICAS II, optimal contact-force parameters for the TactiCath catheter has been defined as 10 grams of force or more during ablation procedures. “Results from the TOCCASTAR study represent an important step forward in contact-force ablation technologies,” said Srijoy Mahapatra, M.D., vice president of medical and scientific affairs, global clinical affairs at St. Jude Medical. “We are confident our large and growing body of clinical evidence demonstrates that the use of contact-force ablation safely reduces the rate of AF recurrence and we look forward to making this important technology available to electrophysiologists in the U.S.”
The TactiCath irrigated ablation catheter is designed to give physicians a real-time, objective measure of the force applied to the heart wall during a catheter ablation procedure. Without contact-force data, physicians must estimate the amount of force applied to the heart wall during an ablation. If too little force is applied, there is a risk of incomplete lesion formation that could result in AF recurrence, potentially requiring additional treatments. If too much force is applied, there is a risk of tissue injury, which can lead to serious procedure-related complications.Data that are produced by the TactiCath irrigated ablation catheter is displayed on the EnSite™ Velocity™ System, a cardiac mapping and navigation system via the EnSite™ Contact Force Module. The EnSite Contact software module, which recently received CE Mark approval, seamlessly integrates contact-force ablation technology and 3-D mapping and navigation capabilities. The study has been conducted to gather data in support of U.S. FDA approval and is the basis for the company’s premarket approval (PMA) submission that has been filed with the FDA. TactiCath has received CE Mark approval and is commercially available in Europe. In the United States, TactiCath is available for investigational use only. The EnSite Contact Force Module is not approved for use in the U.S. About St. Jude MedicalSt. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive, epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media. Forward-Looking StatementsThis news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 29, 2014. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.