boston scientific rhythmia

As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. However, there are no data on the ability of the Rhythmia mapping system (Boston Scientific) to minimize fluoroscopy time and dose. endobj Adjusted earnings per share excludes goodwill and intangible asset impairment charges; acquisition-, divestiture-, litigation- and restructuring-related charges and credits; certain discrete tax items and amortization expense. Electrophysiology Education | Boston Scientific | Educare In these patients, a partial antral ablation was performed for the PVI under HD mapping with the Rhythmia three-dimensional (3D) EAM system (Rhythmia HD system, Boston Scientific, Cambridge, MA). 508-650-8023 (office) Rapid acquisition of high-resolution electroanatomicalmaps using a novel multielectrodemapping system. Atrial fibrillation is a disorder that disrupts the ability of the heart to beat regularly and pump blood efficiently. Boston Scientific is offering the Rhythmia Mapping System with the company's 64 electrode IntellaMap Orion Mapping Catheter, which has also received CE Mark approval. That enhanced clarity can help improve patient outcomes and long-term success rates. Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. RHYTHMIA HDx is a ground-breaking cardiac mapping system that allows surgeons to quickly and accurately identify and treat electrical anomalies inside the heart that cause arrythmia. Unable to load your collection due to an error, Unable to load your delegates due to an error. Di Cori A, Zucchelli G, Segreti L, Barletta V, Viani S, Paperini L, Della Tommasina V, Cellamaro T, Vecchi A, Soldati E, Bongiorni MG. Int J Cardiovasc Imaging. NATICK, Mass., July 24, 2013 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rhythmia Mapping System, a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology (EP) procedures to diagnose or treat a variety of conditions in which the heart beats abnormally. doi: 10.1161/CIRCEP.116.004510. Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. 7) :o,;VOYaCpzfk`+s_7[^G^+DeHuVhu_x$Fsc:dwwl_O7hs5d y%ljC2Y7U:*!alUcfO_G(fC;J{q`N? Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. Instead, it will purchase a minority stake of around 10%. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. Find out who we are, explore careers at the company, and view our financial performance. Boston Scientific Launches DIRECTSENSE Technology - PR Newswire >> 2021 May;32(5):1296-1304. doi: 10.1111/jce.15023. Walsh KA, Galvin J, Keaney J, Keelan E, Szeplaki G. Clin Res Cardiol. Advanced signal processing hardware supports unlimited data point collection. Accessibility 2020 Sep;36(9):1599-1607. doi: 10.1007/s10554-020-01884-8. Management uses adjusted earnings per share along with other supplemental non-GAAP measures to evaluate performance period over period, to analyze the underlying trends in our business, to assess its performance relative to its competitors, and to establish operational goals and forecasts that are used in allocating resources. /Type /ExtGState Electrophysiology / RHYTHMIA Cardiac Mapping System / RHYTHMIA HDx Mapping. More Cardiac Mapping and AblationProducts. "Bringing the Rhythmia system to our electrophysiology customers is a major step toward realizing our vision to redefine ablation technology.". If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. 2022 Apr 11;9:856145. doi: 10.3389/fcvm.2022.856145. /Annots 12 0 R INTELLANAV OPEN-IRRIGATED Indications, Safety and Warnings All rights reserved. /S /URI Indications, Safety and WarningsRHYTHMIA HDx Indications, Safety and Warnings LABSYSTEM PRO Indications, Safety and Warnings * NOTE: Ablation Connection Boxes are components of the Ablation System. Bethesda, MD 20894, Web Policies Fluoroscopy reduction; Low fluoro; Rhythmia mapping system. Late-breaking Clinical Trial Data Further Demonstrate Safety and 9 0 obj Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. I've had 3 years of experience in electrophysiology and 3D cardiac mapping. The RHYTHMIA HDx Mapping System offers industry-defining cardiac mapping, a powerful analysis toolset designed to streamline targeting and clinical decision-making, and unique insights into tissue substrate and lesion formation during RF ablation. Cautionary Statement Regarding Forward-Looking Statements. One of the original mapping systems the Localisa ( Medtronic plc 2015) has been replaced by three systems which are used most commonly in clinical practice which include CARTO ( Biosense Webster, Inc), NavX Precision (St Jude Medical, St Paul, MN, USA) and Rhythmia (Boston Scientific Way Marlborough, MA, USA). RHYTHMIA HDx Mapping System - Boston Scientific EP 447110 AB RHYTHMIA Live Case Video FINAL - YouTube Most 3-D mapping systems provide improved tracking of catheters and enable radiation exposure to be reduced or even eliminated. Global Media Relations 2023 Boston Scientific Corporation or its affiliates. Current mapping systems require a manual, labor intensive process to create maps, making tradeoffs between accuracy and speed. /Pattern << As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Federal government websites often end in .gov or .mil. About Boston Scientific Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. Cardiac Electrophysiology Online Training Courses | EDUCARE All rights reserved. Debreceni D, Janosi K, Vamos M, Komocsi A, Simor T, Kupo P. Front Cardiovasc Med. RHYTHMIA HDx Indications, Safety and Warnings These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. INTELLAMAPORION High-Resolution MappingCatheter. Cardiac Mapping System - RHYTHMIA HDx - Boston Scientific Safety and Efficacy of Minimal- versus Zero-fluoroscopy Radiofrequency Catheter Ablation for Atrial Fibrillation: A Multicenter, Prospective Study. Left atrial activation map image courtesy of Elad Anter, MD, BIDMC. [ 8 0 R ] Images of the Rhythmia Mapping System and IntellaMap Orion High Resolution Mapping Catheter are available for download here. Epub 2018 Feb 23. INTELLANAV MIFI XP Indications, Safety and Warnings Each is essential in creating high-definition maps. sharing sensitive information, make sure youre on a federal 8600 Rockville Pike PtaszekLM, et al. Rhythmia Mapping Specialist - Boston Scientific - LinkedIn For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. Device setup, user manuals and troubleshooting, Boston Scientific Receives CE Mark Approval For The Rhythmia Mapping System, Company Offers Mapping System with IntellaMap Orion Mapping Catheter in Effort to Significantly Enhance Physician Treatment Options, Lab Agent - Restock Products For Your Practice, Bladder leakage and pelvic organ prolapse, Enteral feeding tube and esophageal stent device support, Cardiac Resynchronization Therapy (CRT) device support, Peripheral Artery and Vein interventions device support, Transcatheter Aortic Valve Replacement device support, Spinal Cord Stimulator (SCS) systems device support, EDUCARE Medical Education and Training Courses, ADVANTICS Innovative Healthcare Solutions, Do not sell or share my personal information. 2022 Boston Scientific Corporation or its affiliates. /Subtype /Link As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. Lori Shamroth Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Based on approximate mapping speed of 491 pts / minute in the right atrium in 5 swine USING THE BOSTON SCIENTIFIC RHYTHMIA MAPPING & NAVIGATION SYSTEM. Gagyi RB, Noten AME, Lesina K, Mahmoodi BK, Yap SC, Hoogendijk MG, Wijchers S, Bhagwandien RE, Szili-Torok T. J Interv Card Electrophysiol. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. << 2023 Boston Scientific Corporation or its affiliates. >> Built from the ground up for high-definition cardiac mapping, the RHYTHMIA HDx Mapping System provides unprecedented mapping to allow you to asses with greater efficiency, deliver targeted therapy and confidently achieve procedural endpoints, even in complex substrates. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. "We are committed to developing technologies that surround electrophysiologists with innovative solutions designed to meaningfully improve patient outcomes and increase operational efficiencies," said Pete Sommerness, general manager, Electrophysiology, Boston Scientific. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. endobj Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All trademarks are property of their respective owners. Rachel Longoria - Rhythmia Mapping Specialist II - Boston Scientific Find out who we are, explore careers at the company, and view our financial performance. BARCELONA, Spain and MARLBOROUGH, Mass., March 20, 2018 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced real-world data from the TRUE-HD study during a late-breaking clinical trial session today at the annual congress of the European Heart Rhythm Association (EHRA) in Barcelona, Spain.The data demonstrated the RHYTHMIA Mapping System, when paired with the INTELLAMAP . << 8 . HCP resources Based on approximate mapping speed of 95 pts / minute in the right atrium in 5 swine USING THE ST. JUDE MEDICAL PRECISION ENSITE MAPPING SYSTEM. Poster Session PO097 APHRS 2015. A new mapping method with the Rhythmia navigation system - PubMed /Font << Available exclusively on the RHYTHMIAHDx Mapping System, DIRECTSENSE Technology features a unique local impedance measure that reveals powerful insights into tissue resistivity and subsurface heating. /Filter /FlateDecode >> Detailed Description: Pulmonary venous conduction recovery is found in most patients undergoing redo ablation procedures for atrial fibrillation (AF). It has been shown to allow for 5x faster data collection, with 25 more data points than standard mapping systems and has a clinically proven 0.01mV noise floor. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that are used in a broad range of interventional medical specialties. INTELLAMAP ORION Indications, Safety and Warnings 2. /XObject << endobj Learn more about solutions for your specialty area, Device setup, user manuals and troubleshooting. Radiofrequency catheter ablation of common-type atrial flutter guided by conventional versus electroanatomical mapping. More Cardiac Mapping and AblationProducts. The site is secure. INTELLANAV XP Indications, Safety and Warnings Leanne Kemp - Rhythmia and Core Product Manager - Boston Scientific Electroanatomic Mapping | SpringerLink These forward-looking statements include, among other things, statements regarding our business plans and growth initiatives, the mapping technology, markets for our products, regulatory approvals, new product launches and launch cadence, product performance and importance, timing of closing, expected accretion and dilution and financial performance. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the . 1 0 obj Rx only. LABSYSTEM PRO works with the RHYTHMIA HDx Mapping System to help you improve workflow management and access your patients EP study data from any location, in or out of thelab. Founded in 2004 by Leon Amariglio and Doron Harlev, Rhythmia Medical, Inc. is developing a next generation mapping, visualization and navigation system for the treatment of cardiac arrhythmias. The GAAP financial measure most directly comparable to adjusted earnings per share is GAAP earnings per share. /A << For more on the HDx system, visit their website. Boston Scientific is offering the Rhythmia Mapping System with the company's 64-electrode IntellaMap Orion High Resolution Mapping Catheter, which has also received FDA 510 (k) clearance. LABSYSTEM PRO works with the RHYTHMIA HDx Mapping System to help you improve workflow management and access your patients EP study data from any location, in or out of thelab. << J IntervCard Electrophysiol. INTELLAMAP ORION Indications, Safety and Warnings SKU: M004RAPATCH1 Weight: 3.00 LBS Shipping: Calculated at checkout Quantity: Save Share Product Description M004RAPATCH10 Rhythmia Mapping System Location Reference Patch kit. Pulsed Field Ablation RHYTHMIA HDx EP Conference and Symposium HCP resources CONTINUING THE FARAPULSE PFA JOURNEY: Tissue selective ablation and impact on safety Associate Professor Neven describes the impact of the FARAPULSE PFA system on safety and tissue selective ablation. National Library of Medicine RHYTHMIA HDx combines advanced signal-processing hardware, a novel algorithm that can process unlimited data and the INTELLAMAP ORION Mapping Catheter to give you unparalleled HD cardiac mapping to tackle the most complex procedures. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Epub 2014 Jun 5. NATICK, Mass., May 10, 2013 /PRNewswire/ --Boston Scientific Corporation (NYSE: BSX) has received CE Mark approval for the Rhythmia Mapping System, a next-generation 3D mapping and navigation solution for use in cardiac catheter ablations and other electrophysiology (EP) procedures to treat a variety of conditions in which the heart beats abnormally. Connects to the INTELLAMAP ORION Mapping Catheterand other compatible EP catheters. Electrophysiological studies and ablation procedures expose both physicians and patients to a significant amount of radiation. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. /URI (http://www.prnewswire.com/) Anter, E., et al., Evaluation of a novel high-resolution mapping technology for ablation of recurrent scar-related atrial tachycardias. eCollection 2022. References: Copyright 2019 Elsevier Inc. All rights reserved. Magnetic tracking supports Boston Scientific navigation-enabled catheters, providing maximum accuracy and efficiency. BOSTON SCIENTIFIC RHYTHMIA HDx is a ground-breaking cardiac mapping system that allows surgeons to quickly and accurately identify and treat electrical anomalies inside the heart that cause arrythmia. RHYTHMIA HDx System Overview - Boston Scientific Designed to work with the RHYTHMIA HDx cardiac mapping system, INTELLAMAP ORION is the only mapping catheter engineered to support high-definition mapping for unprecedented clarity in a range of casesfrom simple to the most complex. For more information, please visit: http://www.bostonscientific.com/. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. Find out who we are, explore careers at the company, and view our financial performance. 2012 Nov 22. MeSH The Rhythmia Mapping System is designed to increase speed and improve density of mapping compared to existing systems, potentially offering significant benefit to patients, physicians and health care systems. /GSa 3 0 R "Rhythmia Medical's revolutionary mapping technology is expected to significantly enhance physician treatment options and ultimately facilitate and improve what today are long and complicated procedures," said Doron Harlev, co-founder and co-chief executive officer of Rhythmia Medical. The RHYTHMIA HDx Cardiac Mapping System features a scalable hardware platform and offers automated, rapid acquisition of true high-definition maps that provide the accuracy, precision and efficiency youneed. << As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Designed to work with the RHYTHMIA HDx Cardiac Mapping System, INTELLAMAP ORION supports HD mapping, providing unprecedented clarity in a range of casesfrom simple to the most complex. RHYTHMIA HDx combines advanced signal-processing hardware, a novel software algorithm that can process unlimited data and the INTELLAMAP ORION High-Resolution Mapping Catheter to give you unparalleled Ultra High-Definition mapping to tackle the most complex procedures. media@bsci.com, Michael Campbell Affera, Inc. - Innovative Solutions for the Treatment of Cardiac Arrhythmia Data at Heart Rhythm 2023 Highlight Key Boston Scientific Therapies Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Tech, a Korean company that builds surgical tools. Please enable it to take advantage of the complete set of features! Mantziari L, Butcher C, Kontogeorgis A, Panikker S, Roy K, Markides V, Wong T. Utility of a Novel Rapid High-Resolution Mapping System in the Catheter Ablation of Arrhythmias: An Initial Human Experience of Mapping the Atria and the Left Ventricle. Our advanced, flexible open-architecture system gives you the freedom to customize your toolset. Boston Scientific 2013-2014 Vice President, Product & Technology Boston Scientific 2012-2013 Circ Arrhythm Electrophysiol. "We are committed to developing technologies that surround electrophysiologists with innovative solutions designed to meaningfully improve patient outcomes . All rights reserved. Boston Scientific currently expects the net impact of this transaction on adjusted earnings per share to be immaterial for years 2013 and 2014 and break-even to accretive thereafter, and more dilutive on a GAAP basis as a result of acquisition-related net charges and amortization, which will be determined during the fourth quarter. /ColorSpace << This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Find products, medical specialty information, and education opportunities. Boston Scientific Corporation >> 11 0 obj Jun 2021 - Present2 years Indiana, United States - Develops and implements sales strategies by determining the relevant factors of existing and potential accounts to effectively promote the. PI partnered with the development team to bring this system from an early pilot run into full stage production. /SM 0.02 Familiar handle includes an actuator to enhance controlled deployment of the basket from diameters of 3-22mm. 13(10): p. 2048-2055. Before Catheter ablation enabled by three-dimensional mapping and navigation is commonly used to treat many heart rhythm disorders, including atrial flutter and atrial fibrillation. "I believe the Rhythmia Mapping System will become the new gold standard for mapping and navigation," said Warren Jackman, M.D, professor of Medicine, University of Oklahoma Health Sciences Center. CONTACT: }Y]?6squu?___Gn/|EW}uXy>~#lqONzZ:]n~:_h}:1T{U>Co;ux(_~ _~i5=w7jt:)oLWe"? >> Explore clinical data, case studies and physician perspectives about the unprecedented clarity offered by the RHYTHMIA mappingsystem. Find the information you need, whether you've been diagnosed with a health condition, have an implanted device, or need support. "We believe the Rhythmia Mapping System can become a leader in EP mapping with unparalleled speed, clarity and simplicity which should enable electrophysiologists to perform procedures with great efficiency and precision," said Pete Sommerness, general manager, Electrophysiology, Boston Scientific. Each is essential in creating high-definition maps. The .gov means its official. The INTELLAMAP ORIONMapping Catheters unique, efficient design delivers clear, complete signals with elegant, agile control. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Key Resources Directions for Use Brochure Indications, Safety and Warnings RECEIVE PRODUCT UPDATES Request a Sales Rep Boston Scientific Corporation (NYSE:BSX) entered into a definitive agreement to acquire Rhythmia Medical, Inc. from Norwich Ventures and other shareholders for approximately $270 million in cash on October 8, 2012. government site. /Title ( D a t a a t H e a r t R h y t h m 2 0 2 3 H i g h l i g h t K e y B o s t o n S c i e n t i f i c T h e r a p i e s - M a y 2 0 , 2 0 2 3) /Producer ( Q t 4 . See all our electrophysiology products that work with the RHYTHMIAHDx mapping system. Boston Scientific is offering the Rhythmia Mapping System with the company's 64 electrode IntellaMap Orion Mapping Catheter, which has also received CE Mark approval. /ExtGState << The intelligence built into the system virtually eliminates the need for manual annotation, which is expected to facilitate the diagnosis, treatment and final verification of arrhythmias.".
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