Advanced Cardiac Therapeutics of Laguna Beach, CA has begun trialing its TEMPASURE ablation catheter for atrial fibrillation, flutter, and other cardiac arrhythmias. The company hopes that it will obtain positive results from the trial that will open a door to receiving the European CE mark in a near future. The device is capable of measuring local temperature of the treated area, providing real time information about how well the ablation is affecting cardiac tissue, while delivering saline irrigation through the same catheter.
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. The system’s novel passive sensing microwave radiometry technology allows the electrophysiologist to measure the temperature of cardiac tissue at three millimeters depth during the ablation procedure, providing real-time information that enables proper energy delivery and lesion control.
“ACT’s novel catheter system directly measures lesion creation through temperature, addressing a longstanding problem for physicians performing irrigated cardiac ablation,” said Karl-Heinz Kuck, M.D., head of the Department of Cardiology, St Georg Hospital, Germany, who is co-principal investigator of the trial. “I’m very excited about the promise of this new technology to increase the safety and success of cardiac ablation procedures.”
“I found the ACT system straightforward to use, requiring no different handling or training,” said Yves Vandekerckhove, M.D., chairman of the Department of Cardiology at Sint Jan Hospital in Bruges, Belgium, who performed the first-ever procedure with the system. “Even in the first few patients, we were able to see clinical therapeutic outcomes that closely matched the temperature measurements. The patients I have treated are doing very well.”
“Many years ago, the addition of a thermocouple enabled precise temperature control and temperature mode energy delivery to standard RF catheters. In a similar way, this microwave radiometry technology promises to significantly advance the way we perform irrigated RF ablations for patients with cardiac arrhythmias,” said Pedro Brugada, M.D., professor of Cardiology, chairman and scientific director, Cardiovascular Division, UZ Brussel, Brussels, Belgium, the study’s co-principal investigator.
The prospective, multi-center, single arm study will enroll up to 30 patients with atrial flutter in Europe and New Zealand. Patients enrolled in the trial will be studied during ablation, with follow up at seven and 30 days. Operators are blinded to the microwave radiometer signal in the trial procedures, using ACT’s catheter in exactly the same way as for current irrigated procedures.
Product page: TEMPASURE…
Press release: Advanced Cardiac Therapeutics Initiates First-In-Man CE Mark Clinical Trial to Study Innovative Catheter System for the Treatment of Atrial Arrhythmias…
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