SANTA CLARA, Calif., March 28, 2016 /PRNewswire/ -- Advanced Cardiac Therapeutics, Inc. ("ACT"), the developer of DiamondTemp™, a proprietary open-irrigated temperature-controlled radio frequency ("RF") ablation technology, announced today that enrollment has been completed in its first-in-man clinical trial of thirty five patients suffering from Paroxysmal Atrial Fibrillation ("AFIB"). The study was designed to evaluate the safety and effectiveness of the ACT System, which includes the DiamondTemp Catheter, DiamondTemp RF Generator, Irrigation Pump and various accessories. The patients were treated at Homolka Hospital in Prague, Czech Republic by Dr. Vivek Reddy, Director of Cardiac Arrhythmia Services at Mount Sinai Hospital and by the study's principal investigator, Professor Dr. Petr Neuzil, the Head of the Department of Cardiology at Homolka Hospital.
The DiamondTemp™ proprietary technology features (1) open-irrigated temperature-controlled RF ablation technology, (2) real-time, high-resolution electrogram ("EGM") amplitude attenuation during ablation, and (3) tissue contact sensing. The ACT first-in-man experience demonstrated that its system's features worked in harmony to optimally and safely control lesion formation, to significantly decrease total RF "ON" time and average ablation durations and to reduce overall infused fluid volumes.
According to Dr. Neuzil, "The DiamondTemp™ technology's effectiveness in isolating pulmonary veins and in creating transmural lesions, combined with greater than 60% reduction in start-to-finish procedure times, is remarkable. I have not clinically used another ablation system and catheter technology in the electrophysiology space that is as effective as the DiamondTemp™. This is a game changer."
ACT also announced that it is has appointed Dr. Reddy to be the Principal Investigator of its upcoming IDE clinical study that will be conducted to support the FDA's approval of the DiamondTemp™ System. ACT's CEO, Duke Rohlen, commented, "The power of the DiamondTemp™ technology was demonstrated in our 35-patient first-in-man study. We are very excited to continue to partner with Dr. Reddy to bring the DiamondTemp™ technology to patients suffering from AFIB in the United States."
According to Dr. Reddy, "I am extremely pleased to continue to work with ACT to bring this powerful cardiac ablation system to the US market." Dr. Reddy added, "The ACT DiamondTemp™ catheter is remarkable. The efficiency of this system, based on the lesion feedback it provides combined with the dramatic reduction in treatment times, will make this technology a powerful force in electrophysiology and will change the way that I currently treat patients in my practice."
About Advanced Cardiac Therapeutics, Inc.
Advanced Cardiac Therapeutics, Inc. is a pre-commercial, medical device company that designs and manufactures a catheter-based system for the treatment of patients with AFIB. AFIB is characterized by an irregular, often rapid heart rate that commonly causes poor systemic blood flow. The Company's mission is to dramatically improve the treatment of AFIB through the introduction of products based on its proprietary catheter and generator system. ACT's DiamondTemp™ technology is the only system in the world to leverage four unique capabilities: temperature control, low irrigation flow rates, high resolution EGM attenuation and contact sensing. The ACT system is not currently approved for commercial use. For more information, please contact Whitney Gilmour at email@example.com. www.actmed.net
CONTACT: Whitney Gilmour, (408) 550-6421, firstname.lastname@example.org
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SOURCE Advanced Cardiac Therapeutics, Inc.