Advanced Cardiac Therapeutics, Inc. has received the European CE Mark for its TEMPASURE cardiac ablation catheter. The device is capable of measuring local temperature of the treatment area, helping prevent overheating, while delivering saline irrigation.
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.
The introduction of saline irrigation to catheter ablation yielded a number of positive benefits, but one of the disadvantages of saline irrigation was the loss of temperature feedback. Today, most clinicians use power settings to drive ablation creation. The clinical issues that arise from this approach are two-fold: 1) lesion quality is poorly understood because it is impossible to know if the ablation is merely stunning the tissue or reaching the required temperature (specifically at depth) to effectively ablate the heart wall tissue and 2) current ablations pose a safety risk because there is no determinable way to know when you have reached the desired temperature – and the risk of overheating remains.
The TEMPASURE™ cardiac ablation catheter enables for the first time knowledge of temperature measurement at 3 mm depth and saline-irrigation. VERITAS™ Technology, a proprietary microwave radiometry system, continually reads the temperature 3 mm below the heart wall surface providing EP Physicians with greater control and real-time, more accurate information regarding validation of lesion creation and completeness. Finally – a catheter that provides information previously believed to be unattainable.
Press release: Advanced Cardiac Therapeutics Announces CE Mark Clearance For Innovative Catheter System for the Treatment of Atrial Arrhythmias …
Product page: TEMPASURE…
Flashbacks: TEMPASURE Cardiac Ablation Catheter Measures Temperature of Treated Tissue