CGCI Published in the Circulation Journal of American Heart Association
INGLEWOOD, Calif. – Magnetecs Corporation, a designer and manufacturer of robotic catheterization control systems for minimally invasive surgical procedures, today reported that a paper entitled “Dynamically Shaped Magnetic Fields: Initial Animal Validation of a New Remote Electrophysiology Catheter Guidance and Control System” has been published online in advance of its appearance in the print version of the medical journal Circulation: Arrhythmia and Electrophysiology, published by the American Heart Association.
The paper summarizes the results of the initial feasibility study of remote electroanatomic mapping, navigation, and ablation in animals, performed by the Magnetecs robotic Catheter Guidance Control and Imaging (CGCI) system. Catheter ablations were guided both manually and automatically by the CGCI system to approximately 30 sites per animal in 10 porcine studies. Using the unique closed-loop automated mode, the studies demonstrated 96% reproducibility, defined as the ability to acquire the same stable point 5 consecutive times; repeatability with 91% successful target acquisition; accuracy defined as the maximum final distance from the fixed target point of 1.9 mm; and a time to reach the designated target points of approximately 11.6 seconds.
Dr. Eli Gang, M.D. -Lead Author
“The animal studies summarized in this paper verified that the Magnetecs robotic CGCI system can deliver rapid, stable, reproducible, and highly accurate maneuvering of catheters within the beating heart. The novel CGCI remote navigation system provides near real-time manual as well as automated closed-loop catheter control that is both agile and reproducible. Transmural ablations were achieved in a majority of the lesions even though transmurality was not a goal of the study,” said Dr. Eli Gang, M.D., lead author of the article, Chief Medical Officer of Magnetecs and Clinical Professor of Medicine, Geffen School of Medicine at UCLA.
The paper’s other authors are Dr. Bich Lien Nguyen, M.D., Ph.D., Assistant Professor of Medicine at Sapienza University of Rome; Yehoshua Shachar, CEO, Magnetecs Corporation; Leslie Farkas, former Vice President, Engineering at Magnetecs Corporation; Laszlo Farkas,
Dr. Nguyen and Dr. Gang participating in CGCI animal study
Chief Scientist, Magnetecs Corporation; Bruce Marx, Vice President, Director of Real-Time and Control Software, Magnetecs Corporation; David Johnson, Vice President, Director of Software Engineering, Magnetecs Corporation; Dr. Michael C. Fishbein, M.D, Pathologist, Ronald Reagan UCLA Medical Center; Dr. Carlo Gaudio, M.D., Director, Heart and Great Vessels Department, Sapienza University of Rome; and Steven J. Kim, Senior Director, Advanced Applications, AF Division, St. Jude Medical, Inc.
“The CGCI system is an intuitive platform, and the operator learning curve is short. In its present configuration, CGCI is a practical and flexible system and enhances the capabilities of the electrophysiology catheterization laboratory,” said Dr. Bich Lien Nguyen, M.D., Ph.D., co-author of the paper and Assistant Professor of Medicine at Sapienza University of Rome. “CGCI has been extremely effective during my preliminary experience in animals and patients, and I look forward to the chance to utilize CGCI in clinical ablation procedures. My expectations are that CGCI would make it possible for physicians to better manage clinical workflows and achieve procedural successes.”
Josh Shachar observing Steven Kim of St. Jude Medical processing heart mapping images
SUCCESSFULLY COMPLETED FIRST-IN-MAN CLINICAL TRIALS OF CGCI IN MADRID
The key benefits and the safety and effectiveness of the CGCI system have been further validated in a 40-patient human study that was recently completed under the direction of Dr. Jose Luis Merino Llorens, Director of the Arrhythmia–Electrophysiology Research Unit at Hospital Universitario La Paz in Madrid, Spain. The results of this successful human study were presented by Dr. Merino at the Europace Congress in Madrid on June 27, 2011, in a lecture entitled “Fast Reacting Electromagnets for Remote Navigation of the Mapping Catheter: First Results in Humans.”
Dr. Merino presenting the CGCI system at Europace 2011
In this study, a highly detailed map of the heart was created using the CGCI system in conjunction with EnSite NavX Navigation & Visualization Technology. The primary outcome of the study measured intracardiac anatomic site target acquisition and repetition of acquisition.
“We anticipate that our successfully completed clinical trials in Madrid will be followed by CE Marking for the CGCI platform during the third quarter of 2011. This approval is expected to pave the way for commercial sales of our CGCI system in Europe and parts of Asia,” said Josh Shachar, CEO of Magnetecs Corporation. “Similarly, planned installations at Mount Sinai Medical Center and elsewhere in North America are expected to generate clinical trials for US regulatory clearance and commercialization. We believe that the commercialization of our robotic CGCI system will greatly benefit arrhythmia patients around the world,” Mr. Shachar concluded.
PLANNED CGCI INSTALLATIONS
Magnetecs has completed a definitive agreement to install its CGCI system at Mount Sinai Medical Center in New York City in 2012. In Europe, the company has completed a definitive agreement to install its CGCI system at Na Homolce Hospital in Prague, Czech Republic. Several additional installations are currently planned in the U.S., U.K., Canada, South Korea, Italy, Israel, Scandinavia, and Asia.