Endocardial Solutions Announces Open Platform Cardiac Segmentation Software Development and License Agreement
Endocardial Solutions, Inc. announced an agreement with the Mayo Foundation for Medical Education and Research (the “Mayo Foundation”) for the development and license of an automated three-dimensional (“3D”) cardiac segmentation and modeling software product (the “3D Cardiac Segmentation Software”). Endocardial Solutions (“ESI”) has exclusive rights to cardiac electrophysiology mapping and navigation applications for this software which will be developed in collaboration with the Mayo Foundation Biomedical Imaging Group (“BIR”) using advanced image processing software technology already developed and commercialized by the BIR.
The 3D Cardiac Segmentation Software is designed as an “open platform” that allows physicians to obtain digital scans of a patient’s heart from the computed tomography (CT) or magnetic resonance (MR) imaging system of any manufacturer using current industry standard (DICOM 3), and create a segmented 3D digital image of any individual chamber of the heart. This 3D Cardiac Segmentation Software will be introduced on ESI’s new EnSite high performance Intel(R) Xeon(TM) computer workstation platform, and will enable physicians to view and display actual 3D images of a patient’s cardiac anatomy, which is important in the diagnosis and treatment with ablation therapy of cardiac arrhythmias such as atrial fibrillation. Future versions of ESI’s EnSite Digital Image Fusion (“EnSite DIF(TM)”) technology will enable
electrophysiologists to easily import, display and register these segmented cardiac images with the EnSite System, and then navigate and visualize any conventional electrophysiology catheter in the registered 3D image of the patient’s cardiac chamber anatomy using ESI’s EnSite NavX(TM) nonfluoroscopic navigation technology.
Jim Bullock, President and CEO of the Company, stated, “We are very excited about our partnership with the Mayo BIR to develop this innovative 3D Cardiac Segmentation Software. This 3D Cardiac Segmentation Software is another example of our commitment to enhance the open cardiac mapping and navigation capabilities of the EnSite System and preserve the physicians’ ability to choose which diagnostic and therapeutic product or technology they
use for any particular electrophysiology ablation procedure.” Bullock continued, “We will offer this 3D Cardiac Segmentation Software as a ‘stand-alone product’ that can either be integrated into a customer’s EnSite System or used independently on a separate computer workstation for
pre-surgical planning or post-case review. We are planning to commercially introduce this 3D Cardiac Segmentation Software during the first half of 2005.”
Douglas Packer, M.D., Director of The Applied Basic Electrophysiology Research Lab, and Co-Director for Research of the Clinical Heart Rhythm Laboratory at The Mayo Clinic in Rochester, Minnesota, stated, “The successful ablative treatment of patients suffering from atrial fibrillation requires that physicians be able to visualize and understand the complex anatomy of the left atrium and pulmonary veins, including the number, location, and ostium of the patient’s pulmonary veins, as well as other structures of the heart. The ability to view this anatomy in 3D prior to beginning an atrial fibrillation ablation procedure is an important planning tool. The future capability of visualizing and navigating conventional catheters based on these images, and the ability to integrate them with electrical activation and voltage mapping, may help both improve patient outcomes and decrease procedure times in the future.”
Based in St. Paul, Minnesota, Endocardial Solutions ( www.endocardial.com ) develops, manufactures and markets the EnSite System used for the diagnostic mapping of arrhythmias (abnormally rapid heartbeats caused by irregular electrical activity in the heart) with a 3D graphical display of the heart’s electrical activity, and the navigation and localization of conventional catheters (diagnostic or therapeutic) used during electrophysiology procedures. The U.S. Food and Drug Administration cleared the EnSite System for use in diagnostic mapping of complex arrhythmias in the right atrium of the heart during the second quarter of 1999, and cleared the EnSite NavX Surface Electrode Kit to display the position of conventional electrophysiology catheters in any chamber of the heart in the second quarter of 2003.
The discussion above contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding future product performance and timing of product development and market introduction, that involve a number of risks and uncertainties. A number of factors should be considered in conjunction with
these forward-looking statements. These factors are set forth in the cautionary statements included in Exhibit 99.1 to Endocardial Solutions’ Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission. Endocardial Solutions cautions investors and others to review the statements set forth in that report and that other factors may prove to be important in affecting the business and results of operations of Endocardial Solutions.
