ACT's TEMPASURE cardiac ablation catheter receives CE Mark

Advanced Cardiac Therapeutics, Inc., a developer of innovative temperature-sensing cardiac ablation systems, today announced that the company has received CE Mark (Conformité Européenne) clearance for its TEMPASURE™ cardiac ablation catheter. The TEMPASURE system is the world's first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology.

“We look forward to bringing the TEMPASURE system to patients and physicians in Europe later this year.”

The TEMPASURE system is designed to result in better outcomes for patients by reducing overall procedure time and increasing therapeutic effectiveness, while avoiding rare but serious adverse events that can occur with current technologies. The system's novel passive sensing microwave radiometry technology allows the electrophysiologist to measure the temperature of cardiac tissue during the ablation procedure, providing real-time information that enables proper energy delivery and lesion control. This technology is designed to allow, for the first time, safe and effective automatic RF power titration or "Temperature Mode" irrigated ablation.

"We are very pleased that the TEMPASURE temperature-sensing ablation catheter is now cleared for use in countries that recognize CE Mark," said Peter van der Sluis, the company's CEO. "We look forward to bringing the TEMPASURE system to patients and physicians in Europe later this year."

"For more than 20 years, the temperature sensing and energy titration in 'temperature mode' in non-irrigated traditional RF catheters have been successful and proven tools to safely guide right-sided ablation procedures and optimize outcomes," said Vivek Y. Reddy M.D., The Helmsley Trust Professor of Medicine and director, Cardiac Arrhythmia Service at the Mount Sinai Medical Center in New York. "However, the lack of temperature sensing on the proven irrigated RF catheter platform has limited outcomes in left-sided procedures. I am excited to see ACT's new radiometry technology make available two new features for the first time in left-sided ablation procedures. The company's technology offers real-time safe temperature control during ablations and in the near term promises automatic titration of RF power to create consistent, deep and wide lesions."