Magnetecs CGCI Receives CE Marking for Sales in Europe

Magnetecs, an Inglewood, California firm, received the European CE Marking for its Robotic Catheter Guidance Control and Imaging (CGCI) System.  The technology involves eight remotely controlled electromagnets that guide the movement of a magnetically-tipped EP catheter, providing precise movement with great dexterity. The display intelligently provides validation of anatomy, EP, and precise visualization of the intended work area as well as real-time display of tool location. Automated mapping of the cardiac chamber of interest removes the repetitive task of manual mapping, thereby shortening the duration of the procedure and increasing the accuracy of the generated map. Since all the imaging, tool location and control operates in the digital realm, the entire procedure is stored and available for review and playback.magnetecs

According to Josh Shachar, CEO of Magnetecs, the European regulatory decision will allow the company to apply its technology “for electrophysiology and interventional cardiology as well as additional fields of use.”

The CGCI system has two standard modes of control: Manual Magnetic mode and Automatic Magnetic control mode. The joystick-controlled Manual Magnetic mode provides a responsive way to direct the catheter tip about the chamber. The Automatic Magnetic mode gives the operator point-and-click targeting of map locations. In Automatic Magnetic mode, the CGCI logic routines plan a path to the targeted location, determine the optimal contact direction, and guide the catheter tip until it makes firm and continuous tissue contact. The CGCI system uses the static map geometry to plan a guidance path that will bring the catheter tip into contact with the moving tissue as it passes through the selected map location. The CGCI then uses tissue-contact sensing filters to continue advancing the tip until continuous contact is reached over the entire cardiac cycle. If the catheter slips from the location, the tissue-contact sensing system immediately alerts the operator and the magnetic field regulator, and the tip is quickly guided back into contact at the desired tissue location. If an obstacle is detected, the location is automatically marked, and a new path is planned to tissue contact.

INGLEWOOD, Calif. – Magnetecs Corporation, a designer and manufacturer of robotic catheterization control systems for minimally invasive surgical procedures, today reported that the company’s Robotic Catheter Guidance Control and Imaging™ (CGCI) System has received CE Marking certification.

CE Marking will enable commercialization of CGCI in Europe and support certification in many other parts of the world. The scope of the indication for CGCI’s CE Marking is “Design, manufacture and installation of CGCI System to navigate a magnetic device to designated target sites. Design and manufacture of Catheter Impedance Seeking Device (CISD) as an accessory to CGCI.”

“CE Marking is the key achievement of Magnetecs required to transition from the development phase of our organization to building a commercial enterprise,” said Josh Shachar, CEO of Magnetecs Corporation. “The scope of the indication we have received will enable widespread application of our technology for electrophysiology and interventional cardiology as well as additional fields of use.”

Below is the Magnetecs Regulatory Team, under the direction of David Johnson, Vice President and Director of Software Engineering, responsible for the CE Marking Certification.

CGCI is a unified system for robotic guidance, control and imaging of catheters and other advanced tools used in electrophysiological and other procedures. Previous magnetic guidance systems use large, independent magnets which emit a substantial and continuous magnetic field, have limited control capabilities, and require shielding. In contrast, Magnetecs’ CGCI system creates an electromagnetic field that is largely contained in the electromagnetic array and focused in an area no larger than the patient’s chest. CGCI only emits a magnetic field when in use and can dynamically adjust and manipulate this field to safely and reliably achieve unprecedented three-dimensional catheter-guidance precision and responsiveness.

The CGCI system is integrated with sophisticated cardiac mapping and navigation technologies, including X-ray, intracardiac echocardiography (ICE), and other advanced electrophysiology lab technologies and equipment. Magnetecs is planning additional applications of the Company’s electromagnetic technology in the fields of interventional cardiology, gastroenterology, neurology, and gynecology.

Magnetecs Corporation designs and manufactures a unique and highly efficient robotic catheterization control system for minimally invasive surgical procedures and the advanced specialized tools used in these procedures. The Company believes that its proprietary CGCI system will greatly improve the efficacy, safety and cost efficiency of many common minimally invasive surgeries. Magnetecs has established advanced electrophysiology surgical suites for CGCI development and testing at the Company’s headquarters facility in Inglewood, California.

CE Marking will enable Magnetecs to generate revenue from sales in Europe in countries that include the U.K., Czech Republic, Sweden, Italy, Germany, Switzerland, and Russia.

Magnetecs is planning additional installations in North America in Montreal, Canada, Utah, and New York City in anticipation of the company’s FDA 510(k) submission.


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