ACT study aims to demonstrate safety, efficacy of TEMPASURE catheter

Advanced Cardiac Therapeutics has begun enrolling the first patients in its CE Mark clinical trial of the safety and performance of the company's TEMPASURE cardiac ablation catheter. The study will enroll up to 30 patients with atrial flutter in Europe and New Zealand.

ACT's system is the first RF cardiac ablation catheter to offer both saline irrigation and temperature-sensing technology. Its passive sensing microwave radiometry technology allows the electrophysiologist to measure the temperature of cardiac tissue at 3-mm depth during the ablation procedure, providing real-time information that enables proper energy delivery and lesion control, according to a company statement.

Currently, many patients must have the procedure redone, but ACT's TEMPASURE system may help solve this problem, CEO Peter van der Sluis said in an interview with FierceMedicalDevices. He explained that the company's system is unique, as it is the only one that measures temperature from within the tissue. Switzerland's Endosense, for example, has a catheter that gives doctors a measure of contact force during the catheter ablation procedure, but it doesn't provide a direct measure of the lesion, van der Sluis said. Endosense last month announced the completion of enrollment in the EFFICAS I clinical study using its TactiCath force-sensing catheter.  

ACT opened its doors in 2007 and was co-founded by Dr. Kenneth Carr, who pioneered microwave radiometry technology. The technology was originally employed as a surveillance tool during the Cold War to spy on the Soviet Union's agricultural crop growth from space, according to the company. But its usefulness in other areas has been realized. Indeed, ACT's technology can be used in other ablation procedures, van der Sluis told FMD.

In January 2010, the company completed $5 million Series B equity financing round. The financing was led by NBGI Ventures. The company also has been supported by angel groups, including Life Science Angels, according to van der Sluis.

- see the ACT release 

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