Oct 12 2010
Magnetecs Corporation, a designer and manufacturer of robotic systems for minimally invasive surgical procedures, today reported that human studies have commenced using the Company's Catheter Guidance Control and Imaging (CGCI) system for patients with arrhythmia, or irregular heart beat.
“The start of human studies marks the culmination of many years of hard work for our team at Magnetecs and the commencement of our activities to apply our leading magnetic guidance technology in the service of medicine”
The studies are being conducted at General Universitario La Paz in Madrid, Spain by Dr. Jose Merino, Director of the Arrhythmia & Electrophysiology Research Unit of the hospital. The Principal Investigator for the studies is Dr. Vivek Reddy, Professor of Medicine and Director, Cardiac Arrhythmia Service, Mount Sinai School of Medicine, in New York City. The studies will also be conducted by Dr. Eli Gang, Chief Medical Officer of Magnetecs, Clinical Professor of Medicine, Geffen School of Medicine at UCLA, who has also served as Director of the Clinical Electrophysiology Laboratory at Cedars-Sinai Medical Center in Los Angeles.
"The start of human studies marks the culmination of many years of hard work for our team at Magnetecs and the commencement of our activities to apply our leading magnetic guidance technology in the service of medicine," said Josh Shachar, CEO of Magnetecs Corporation. The initial study will consist of 20 patients in which a highly detailed map of the heart will be created using the CGCI system's magnetically guided catheter. The mapping study is expected to be completed by the end of 2010, and will be followed by a study of 40 patients in which mapping and ablation procedures will be conducted using the CGCI system. The second study is expected to be completed in the second quarter of 2011.
CGCI HUMAN TRIALS IN MADRID FOR CE MARK CERTIFICATION
CGCI uses eight electromagnets in a unique configuration to intelligently guide a magnetically-tipped catheter, enabling a physician to precisely and consistently control surgical tools in highly dynamic or previously inaccessible environments while enhancing both the physician's dexterity and the patient's safety. The first study in mapping of the heart is a diagnostic procedure that is performed for patients who have arrhythmia, or irregular heart beat. Magnetecs expects this study to lead to a CE Mark application for commercialization in Europe planned for the first half of 2011. Additional human studies for ablation are expected to lead to approval of the CGCI system for therapeutic procedures used to correct heart arrhythmia.
PLANNED CGCI INSTALLATIONS IN LONDON, NEW YORK CITY AND PRAGUE
Additional installations in Europe and the US will support the Company's program to receive FDA 510(k) certification. Magnetecs is currently in the initial stages of planning human studies in the US at Mount Sinai Medical Center in New York City under the direction of Dr. Reddy and Dr. Andre d'Avila, and in the UK at St. Mary's Hospital in London under the direction of Dr. Nicholas Peters and Dr. Wyn Davies. CGCI installations and studies are also currently being planned at Na Homolce Hospital in Prague, Czech Republic.
Source: Magnetecs Corporation
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