Endosense 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.
“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 soon 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+ fibre 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, electro-physiologists 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.
