ACT gets CE Mark for TEMPASURE system

Laguna Beach, CA-based Advanced Cardiac Therapeutics has received CE Mark clearance for its Tempasure cardiac ablation catheter. The system is the world's first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology, according to the company.

The system is designed to reduce overall procedure time and increase therapeutic effectiveness while avoiding 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.

Cardiac catheter ablation procedures involve advancing a catheter into the heart and selectively ablating certain areas of tissue to prevent the spread of electrical signals that give rise to the arrhythmia. But most catheter ablation procedures are now conducted with irrigated catheters, in which saline is pumped through the tip during the application of energy to prevent the tip from overheating and increasing risk of blood clotting events. However, as the tip is cooled, it is not possible to estimate the effect of the energy on the tissue by measuring the temperature at the surface of the tissue. In most of these blind procedures, almost half don't reach the goal temperature of 60 degrees celsius, according to Peter van der Sluis, the company's CEO.

"[T]he lack of temperature sensing on the proven irrigated RF catheter platform has limited outcomes in left-sided procedures," said Vivek Reddy, The Helmsley Trust Professor of Medicine and director, Cardiac Arrhythmia Service at the Mount Sinai Medical Center in New York. "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."

The catheter should be coming to the EU market later this year, and will be used in 20 to 25 sites throughout the region, van der Sluis told FierceMedicalDevices. Because it will require no re-education of healthcare providers to be able to use the technology, the company foresees an easier introduction into the marketplace. It also hopes to explore the use of its technology in additional therapeutic options and will provide more information early next year. Van der Sluis added that he is excited by the product, as it dramatically increases the success rate, thus reducing the need for repeat procedures and clearing the way for new patients to be treated.

- see the ACT release

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