The CONFIDENSE™ Module’s Proprietary Algorithm Streamlines Data Collection, Annotation and Validation for the Market-Leading CARTO® System
Diamond Bar, Calif., June 18, 2015 – Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced today the launch of the CONFIDENSE™ Module, an innovative technology that streamlines the creation of real-time three-dimensional (3D) maps of a patient’s cardiac structures during catheter ablation procedures. Utilizing an advanced, proprietary algorithm, the CONFIDENSE™ Module enhances the process for validating information, or “points,” acquired during multi-electrode mapping, enabling electrophysiologists to focus their time and expertise on the most relevant data during the mapping process.
“While high-density maps generated through multi-electrode mapping provide the most comprehensive and accurate image of the cardiac structures, this process can prove to be time intensive,” said Vias Markides, MD, Director of the Heart Division at Royal Brompton Hospital, London, United Kingdom. “The new CONFIDENSE™ Module streamlines the mapping and validation process, which has the potential to reduce overall mapping, annotation and re-annotation time. I’m pleased that continued innovation in this space is enabling us to realize important clinical efficiencies while preserving the critical data and accuracy we have come to rely on from the CARTO® System.”
Multi-electrode mapping allows for the rapid acquisition of a large quantity of data used to generate detailed, high-density maps on the CARTO® 3 System. Previously, validating the information acquired through multi-electrode mapping required a very detailed manual process but the new CONFIDENSE™ Module enhances the 3D mapping experience with several novel features that simplifies and accelerates map creation while maintaining accuracy. The module also provides a real-time assessment of whether catheter electrodes are in proximity with heart tissue while selectively utilizing the points closest to the tissue to generate a high-quality 3D map, enhances the consistency of quality data acquisition with an advanced algorithm, and accurately identifies and quickly evaluates points whose timing is judged to be inconsistent in comparison with neighboring points, which are then flagged and immediately brought to the physician’s attention.
“We are committed to collaborating closely with the clinical community to introduce novel innovations that not only enable access to the most accurate and comprehensive mapping data available, but in making the acquisition of this data fast, simpler and more intuitive for users,” said David Shepherd, U.S. President, Biosense Webster, Inc. “We are excited to introduce this latest innovation for our foundational CARTO® System platform, a fully integrated system that delivers the most comprehensive suite of solutions for physicians worldwide.”
The CONFIDENSE™ Module is CE Marked in Europe and received 510(k) clearance in the United States where it will be widely available in July.
About Biosense Webster’s CARTO® 3 System
The CARTO® 3 System is an advanced imaging technology that utilizes electromagnetic technology to create real-time 3D maps of a patient’s cardiac structures. The system is designed to help electrophysiologists navigate the heart by generating an accurate 3D map, as well as pinpointing the exact location and orientation of catheters in the heart during catheter ablation procedures for patients suffering from heart rhythm conditions (cardiac arrhythmias). During catheter ablation, doctors insert a therapeutic catheter through a small incision in the groin where it is then weaved up to the heart through a blood vessel. Once it reaches the left upper chamber or the heart (atrium), radiofrequency energy is delivered to the heart wall to create lesions that block faulty electrical impulses that can cause heart rhythm disorders.
About Biosense Webster
Biosense Webster is the global leader in the science of diagnosing and treating heart rhythm disorders. The company partners with clinicians to develop innovative technologies that improve the quality of care for arrhythmia patients worldwide. Biosense Webster is part of the Johnson & Johnson Family of Companies. More information can be found at www.biosensewebster.com.
Dr. Markides is paid for training and educational services provided to Biosense Webster, Inc.
Caution Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the CARTO® 3 System CONFIDENSE™ Module. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Biosense Webster, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; manufacturing difficulties and delays; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 28, 2014, including in Exhibit 99 thereto, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Biosense Webster, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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