St. Jude Medical Acquires Endosense
St. Jude Medical adds ablation catheter with contact-force measurement to its atrial fibrillation portfolio and accelerates U.S. timeline for AF ablation indication
August 19, 2013 — St. Jude Medical, Inc. today announced the acquisition of Endosense SA, a Switzerland-based company that has pioneered contact-force measurement in catheter ablation.
Endosense Force-Sensing Technology
Endosense developed the TactiCath irrigated ablation catheter to give physicians a real-time, objective measure of the force they apply to the heart wall during a catheter ablation procedure. Without contact-force data, physicians have to 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.
“Force sensing is a tremendous advancement in cardiac ablation that will potentially improve safety and efficacy, likely becoming a standard for all cardiac ablations,” said Dr. Vivek Reddy, professor of medicine and principal investigator in the TOCCASTAR trial at Mount Sinai Hospital, N.Y.
There is a growing body of evidence to support the safety and effectiveness of contact-force ablation technology, including Endosense’s TOCCATA, EFFICAS I and EFFICAS II studies, which have collectively demonstrated safety and reduced rate of AF recurrence when contact force was used. TactiCath is CE Mark approved for atrial fibrillation (AF) and supra ventricular tachycardia (SVT) ablation. In addition, Endosense just completed its U.S. IDE trial – the TOCCASTAR trial – and plans to submit its pre-market approval application to the U.S. Food and Drug Administration (FDA) in support of a paroxysmal AF indication before the end of 2013.
"TactiCath offers important improvements over previous-generation ablation catheters,” said Prof. Dr. Karl-Heinz Kuck, director of cardiology at St. Georg Hospital in Hamburg, Germany. “While low contact force can lead to ineffective lesions, excessive contact force can cause safety concerns. The ability to more precisely measure this force improves procedural efficiency and provides increased confidence that an ablation will be effective in treating complex cardiac arrhythmias."
Founded in Geneva in 2003, Endosense is a medical technology company focused on improving the efficacy, safety and accessibility of catheter ablation for the treatment of cardiac arrhythmias. The company pioneered the use of Contact Force measurement in catheter ablation with the development of the TactiCath, the industry’s first force-sensing ablation catheter. Endosense is backed by Edmond de Rothschild Investment Partners, NeoMed Management, Gimv, VI Partners, Sectoral Asset Management, Ysios Capital Partners, Initiative Capital Romandie and NGN Capital. For more information, visit www.endosense.com or www.sjm.com.