Endosense Achieves ISO 13485 Certification

Endosense, a medical technology company focused on enabling the broad adoption of catheter ablation for the treatment of cardiac arrhythmias, has been awarded ISO 13485:2003 certification for its quality management system by the certification authority NSAI. The international standard for the medical device industry, ISO 13485:2003 verifies Endosense’s ability to provide medical devices and related services that consistently meet customer needs and regulatory requirements. 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. With TactiCath, physicians can be assured that they are using just the right force for the right lesion creation. “Receiving ISO 13485 certification confirms that our quality standards are among the best in the industry, and it represents a major step towards the successful clinical evaluation and commercialization of our breakthrough TactiCath product,” said Eric Le Royer, president and chief executive officer, Endosense. “We look forward to having the first human case performed in Europe within this quarter and anticipate a CE Mark for TactiCath in 2009.” The TactiCath is a high-end, 8.5F sheath compatible, open irrigated, steerable catheter that seamlessly integrates Endosense’s proprietary Touch+™ fiber optic sensor technology at the catheter tip. It is the first force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Without this measure, electrophysiologists have had to estimate — and frequently guess — the level of contact force required, as too little force may render the procedure ineffective and too great a force may perforate the heart wall. TactiCath has undergone extensive preclinical testing in the United States and Europe. Endosense’s growing body of study data on TactiCath has been the subject of nine abstracts presented at annual meetings of the Heart Rhythm Society, American College of Cardiology and American Heart Association.