UIRF began working with Mickelsen in 2012, assisting with the disclosure of two inventions related to atrial fibrillation treatment, both adaptations to the catheter used for treatment delivery (the second nicknamed the ring of fire). UIRFs licensing relationship with Farapulse enabled Dr. Mickelsen to amplify the impact of his university research, UIRF Executive Director Marie Kerbeshian said. The FARAPULSE PFA System was purposefully built from the ground-up; optimized to deliver a safe & effective electric field for cardiac PFA therapy while offering a simple user experience. Credit: Boston Scientific. A weekly roundup of the latest news and analysis, sent every Friday. ", Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27 percent. Reddy VY, Neuzil P, Koruth JS, et al. supplied with each device. Faculty are required to inform UIRF when theyve developed research with potential commercial value. All trial sites have been identified and more than 100 patients have been enrolled to date in the prospective, randomized trial. INFORMATION purposes only and may not be approved or This PFA system comprising a sheath, generator, and cathetersis intended to ablate heart . . Boston Scientific noted that the Farapulseacquisition will support its current electrophysiology portfolio by adding the FARAPULSE Pulsed Field Ablation (PFA) System. He congratulated Mickelsen, whom he described as a physician and serial entrepreneur who consistently seeks ways to address unmet needs in the field of cardiac electrophysiology.. Reddy VY, Neuzil P, Koruth JS, et al. The FARAPULSE PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimising procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results.. Boston Scientific has been an investor in Farapulse since 2014 and holds an equity stake of approximately 27 percent, according to a news release issued by the company Friday. The company also initiated its pivotal IDE trial in the U.S. the ADVENT trial in March 2021. 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 Factorsin 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 Factorsin Quarterly Reports on Form 10-Q we have filed or will file hereafter. "The more than $6 billion electrophysiology market continues to expand, growing double digits year-over-year,and adding this technology to our existing portfolio enables Boston Scientific to be the only company to offer physicians comprehensive therapeutic options they can select based on clinical preference and individualized patient needs," said Scott Olson, senior vice president and president, Rhythm Management, Boston Scientific. scientific boston pta hardware overview ppt powerpoint presentation slideserve. The transaction is anticipated to close in the third quarter of 2021, subject to customary closing conditions. Recently, sentiment has changed. When typing in this field, a list of search results will appear and be automatically updated as you type. The FARAPULSE PFA System was purposefully built from the ground-up; optimized to deliver a safe & effective electric field for cardiac PFA therapy while offering a simple user experience. Farapulse has developed a pulsed field ablation (PFA) system, which received breakthrough designation in May 2019. Medical solutions company Boston Scientific Corporation ( BSX) has announced that it will exercise its option to acquire the remaining 73% stake in medical technology company Farapulse for $295 million. All rights reserved. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System - a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. The latest deal also comprises clinical and regulatory milestone payments of up to $92m as well as revenue-based payments for the next three years. ", UI Chief Innovation Officer Jon Darsee said the acquisition represents one of the largest deals in the space of cardiac ablation procedures. This is Boston Scientific's 23rd transaction in California. issued by the company Friday. PFA is a non-thermal ablation system indicated to treat atrial fibrillation (AF) as well as other cardiac arrhythmias. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System - a non-thermal ablation system for the treatment of atrial . Unlike thermal methods, which ablate indiscriminately with extreme temperatures, non-thermal FARAPULSE PFA is tissue-selective. On September 21, 2020, Boston Scientific Corp. acquired medical products company Farapulse, Inc. Acquisition Highlights. In June 2021, Boston Scientific Corporation exercised its option and acquired remaining shares of Farapulse, Inc., to complement its existing EP portfolio by including . The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System - a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. 1. UIRF also provided Mickelsen with gap funding to further develop his work, guidance when he decided to form his own company, and help with attracting venture capital. The transaction is likely to close in the third quarter of 2021. (TAVR), Find "The FARAPULSE PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimizing procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results." Explore Educare, our globally recognized education program, Making a meaningful difference in patients' lives. Farapulse develops pulsed-field ablation (PFA) system to treat atrial fibrillation (AF) and other cardiac arrhythmias. Pulsed field ablation of paroxysmal atrial fibrillation: 1-year outcomes of IMPULSE, PEFCAT, and PEFCAT II. , M.D. 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. GlobalDatas focus lies in the critical areas to get right: The leading site for news and procurement in the medical device industry, Receive our newsletter - data, insights and analysis delivered to you. "The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. 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. On an adjusted basis, the transaction is expected to be slightly dilutive to adjusted earnings per share (EPS) in 2021 and 2022, which Boston Scientific expects to offset via internal cost efficiencies and trade-offs. "The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians," said Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific. Boston Scientific Corp. has exercised its option to acquire the remaining shares of University of Iowa startup Farapulse Inc., which has developed a method for precisely and safely treating abnormal heart rhythms. Boston Scientific Exercises Option to Acquire Farapulse, Inc. Acquisition complements company's electrophysiology portfolio to include the only commercially available cardiac pulsed field ablation technology Read More FARAPULSE's Pivotal ADVENT Trial underway with First Patients Treated with its Breakthrough Pulsed Field Ablation System to Treat Atrial Fibrillation Read More "The FARAPULSE PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimizing procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results. Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27 percent. Products, Product ThereemergenceofPFAin cardiac applicationspromises substantialimprovementsin safety andprocedural efficiencycomparedto current techniques. marlborough, mass., sept. 21, 2020 / prnewswire / -- boston scientific corporation (nyse: bsx) today announced it has signed an investment agreement with an exclusive option to acquire farapulse, inc., a privately-held company developing a pulsed field ablation (pfa) system for the treatment of atrial fibrillation (af) and other cardiac Stones, Men's Boston Scientific has been an investor in Farapulse since 2014 and currently holds an equity stake of approximately 27%. Menlo Park, Calif.-based Farapulse has developed a pulsed-field. Prior to use, please consult device labeling for prescriptive information and operating instructions. This material not intended for use 2022 Boston Scientific Corporation or its affiliates. Enter your details here to receive your free Report. The $295 million investment for the remaining 73% stake will include a $92 million payment . . Cautionary Statement Regarding Forward-Looking StatementsThis 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. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements. Atrial Appendage Closure Device, Remote Patient Monitoring and The FARAPULSE PFA System is composed of three main components: FARADRIVE Steerable Sheath designed for access and navigation The company also initiated its pivotal IDE trial in the U.S. the ADVENT trial in March 2021. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. Other health care professionals should select their country in the top right corner of the website. That purchase gives one of the worlds leading medical device manufacturers full access to Farapulses Pulsed Field Ablation (PFA) System, a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. Bespoke Plastic Components for Medical Devices, Medical Adhesives for Medical Device Manufacturers, Thank you for subscribing to Medical Device Network. These forward-looking statements include, among other things, statements regarding the financial and business impact of the transaction, product launches and product performance and impact. Boston Scientific Corporation (NYSE: BSX) today announced it exercised its option to acquire the remaining shares of Farapulse, Inc. Explore our education platform, EDUCARE, to follow recent pulsed field ablation conference, symposium & webinar talks, clinical evidence, and training content. Security, Awards & Boston Scientific will exercise its option to buy the remaining 73% of Farapulse, the first company to market a pulsed field cardiac ablation system. The $295 million buyout for the 73% stake not yet owned will give Boston Scientific 100% ownership. +Preceding consideration of current equity ownership, debt and other closing adjustments, the transaction price consists of $450 million up front, up to $125 million upon achievement of certain clinical and regulatory milestones as well as additional revenue-based payments through calendar year 2023. 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 Factorsin 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 Factorsin Quarterly Reports on Form 10-Q we have filed or will file hereafter. Mickelseninvented a PFA system andadaptedcatheterstodeliverpulsed field electricitytothe tissue fortreating AF. PFA is Highly Parameter Dependent 3 A Heart Specialist, Medical Device ID Cards As a result, the transaction consists of an upfront payment of approximately $295 million for the 73 percent stake not yet owned, up to $92 million upon achievement of certain clinical and regulatory milestones, as well as additional revenue-based payments for the next three years. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. 175 + PATIENTS TREATED. Medical solutions company Boston Scientific Corporation ( BSX) has announced that it will exercise its option to acquire the remaining 73% stake in medical technology company Farapulse for $295 . Following the news, shares of the company declined marginally on Thursday. 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. Boston Scientific has been an investor in Farapulse since 2014 and holds an equity stake of approximately 27 percent. order of a physician. Discover the FARAPULSE Pulsed Field Ablation System 8-application workflow and explore the clinical data behind it in this breakdown animation. Institutional Animal Care and Use Committee, Office of the Institutional Animal Care and Use Committee, High Resolution Mass Spectrometry Facility, Center for Health Effects of Environmental Contamination, Center for Global and Regional Environmental Research, Iowa Center for Research by Undergraduates. If development of Farapulses technologies continued in a positive direction, Boston Scientific indicated it would buy the company. Farapulse developed his discoveries into a commercially-viable product, and now Boston Scientific will ensure that his work will reach patients worldwide., Stephen Pradarelli, Office of the Vice President for Research, 3193841282, Office of the Vice President for Research Pioneering Tissue-Selective AblationThe FARAPULSE Pulsed Field Ablation System is optimized for patient safety and procedural ease, addressing many traditional risks associated with thermal ablation while producing proven, durable pulmonary vein isolations.1. Boston Scientific rhythm management and global health policy senior vice-president and chief medical officer Kenneth Stein said: The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians. As a result, the transaction consists of an upfront payment of approximately $295 million for the 73 percent stake not yet owned, up to $92 million upon achievement of certain clinical and regulatory milestones as well . All Products, Urology It is strictly forbidden to make copies, whether partial or total and on whichever media without prior approval. Featured stories and the latest news on what it takes to advance science for life. - Pacemaker, ICD, & CRT devices, About Your Freedom from AF at one year after a single ablation procedure is the trials primary goal. Farapulse became the first company to commercialize a cardiac PFA technology after receiving CE Mark for the FARAPULSE PFA System in Europe in the first quarter of 2021. Health, Deep 3. Boston Scientific said Thursday that it would pay up to $387 million, including potential milestone payments, for Farapulse, a California-based medical equipment manufacturer that developed a non . Relations. In January, Farapulse obtained CE mark for the FARAPULSE PFA System, making it the first company to market such a device in Europe and other CE mark accepting countries. Right now cardiac electrophysiology iswitnessinga paradigmshiftincatheter ablation toward PFA. About Boston ScientificBoston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. The UI Research Foundation, part of the Office of the Vice President for Research, has played a significant role in bringing Farapulses invention to market. J Am Coll Cardiol. Boston Scientific Corporation (NYSE: BSX) today announced it exercised its option to acquire the remaining shares of Farapulse, Inc. Boston Scientific has signed an investment agreement with privately held medical device company Farapulse with an exclusive option for acquisition. "The emerging field of PFA has the potential to alter the future of ablation therapy and has shown the promise of improvements in both safety of cardiac ablations for patients and efficiency and ease-of-use of these procedures for physicians," Kenneth Stein, M.D., senior vice president and chief medical officer, Rhythm Management and Global Health Policy, Boston Scientific, said. As a result, the transaction consists of an upfront payment of approximately US$295 million for the 73% stake not yet owned, up to US$92 million upon achievement of certain clinical and regulatory milestones as well as . 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. MARLBOROUGH, Mass., June 24, 2021 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it exercised its option to acquire the remaining shares of Farapulse, Inc. Unlike thermal methods, FARAPULSE PFA is cardiac tissue-selective since cardiomyocytes have a lower threshold for damage, which addresses the risk of collateral injury to adjacent structures. massdevice afib. Products shown for For health care professionals in EUROPE excepted those practicing in France as the following pages are intended to all International health care professionals and are not in compliance with the French Advertising law N2011-2012 dated 29th December 2011 article 34. 1. The acquisition will complement the existing Boston Scientific electrophysiology portfolio to include the FARAPULSE Pulsed Field Ablation (PFA) System a non-thermal ablation system for the treatment of atrial fibrillation (AF) and other cardiac arrhythmias. Resynchronization Therapy (CRT) Devices, Chronic "The FARAPULSE PFA System is intended to enable physicians to precisely ablate cardiac tissue while minimizing procedural complications, and real-world and clinical evidence from trials throughout Europe have demonstrated encouraging, positive results. Pain, Kidney Brain Stimulation, Transcatheter Aortic Valve Replacement By downloading this Report, you acknowledge that we may share your information with our white paper partners/sponsors who may contact you directly with information on their products and services. Take action in addressing health inequities in your community. Our innovative technology has been used to treat patients in multiple European clinical studies. 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