Interim Results of Human Studies Using Magnetecs CGCI Robotic Catheter Guidance System to be Presented at Conferences in London and Tel Aviv
Inglewood, CA – Magnetecs Corporation, a designer and manufacturer of robotic systems for minimally invasive surgical procedures, today reported that the Company’s Robotic Catheter Guidance Control and Imaging (CGCI) system and interim results of human studies using CGCI for patients with an irregular heartbeat will be presented at two upcoming international conferences in London and Tel Aviv.
The conferences will include lectures on new remote navigation technologies in the field of cardiology and will contain presentations of the interim results to date of the first human studies of the CGCI system, which began on October 7, 2010, at Hospital General Universitario La Paz in Madrid, Spain.
Dr. Jose Merino and Dr. Eli Gang – Lead Investigators for Magnetecs Human Study of the CGCI
The first conference presentation, “CGCI Robotic System from Magnetecs,” will be made by Dr. Jose Merino, Director of the Arrhythmia & Electrophysiology Research Unit at La Paz Hospital, at the Europe AF Conference on November 23, 2010. The presentation will take place at the London Hilton Metropole Hotel on Tuesday at 1:45 PM.
The second conference, Innovations in Cardiovascular Interventions (ICI), December 5-7, 2010 in Tel Aviv, Israel, will include two presentations on CGCI and the studies conducted to date. The first of these presentations, entitled “Dynamically shaped magnetic fields: Description and animal validation of a new remote catheter guidance and control system,” will be made 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 second CGCI presentation at the ICI conference, entitled “Human study of Magnetecs’ Catheter Guidance Control and Imaging System,” will be made by Dr. Merino. These presentations will be made during the Atrial Fibrillation sessions of the ICI conference beginning at 2:00 PM on December 7, 2010, at the David InterContinental Hotel in Tel Aviv.
CGCI HUMAN STUDIES ONGOING IN MADRID
To date, ten patients have participated in the 20-patient study in which a highly detailed map of the heart is created using the CGCI system’s magnetically guided catheter. The primary outcome of the study measures intracardiac anatomic site target acquisition and repetition of acquisition. Successful outcomes have been achieved in all ten patients thus far participating in the study. A description of the study can be found on the ClincalTrials.gov site.
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. 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.
CGCI SUBMISSION 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 the mapping of the heart is a diagnostic procedure that is performed for patients who have an arrhythmia or irregular heartbeat. 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.
CGCI INSTALLATIONS PLANNED 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.