We are developing a comprehensive, integrated platform that includes RF/PF ablation and mapping catheters, a mapping system . BIBA Medical, North America Search and apply for the latest Rf wireless engineer jobs in Bedford, MA. 3. A) Salary.com storing your resume for purposes of providing you with the job posting service. Study Design Go to Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Familial atrial fibrillation Consistent with the financial impact disclosed in January 2022 when the Affera transaction was announced, Medtronic expects the transaction to be less than 1% dilutive to Medtronic's adjusted earnings per share in each of the first three years, and neutral to accretive thereafter. mapping system using the TactiFlexTM Ablation Catheter, Sensor EnabledTM . pump (HexaFlow; Affera Inc) and an electroanatomical map-ping system (HexaMap, Prism-1; Affera, Inc; Figure 1A). Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. Provide professional support during clinical procedures on the effective use of Afferas ablation and mapping catheters, the mapping system, and the RF/PF ablation system. Willing to work variable hours to meet patient needs. Willing to work variable hours to meet patient needs. Print. CRF is committed to igniting the next wave of innovation in research and education that will help doctors save and improve the quality of their patients lives. Stay current on company product instructions for use, best practices and technical troubleshooting, as well as relevant scientific clinical literature and new product information. The expandable lattice tip of the company's Sphere-9 catheter and integrated Prism-1 mapping and HexaGEN ablation system enable the rapid creation of detailed maps as well as the delivery of controlled, durable lesion sets in a variety of substrates. Email: [emailprotected] The primary role of the Mapping Specialist is to provide expert technical and clinical support and training to physicians and EP lab staff on the effective use of Afferas systems and catheters during clinical procedures. Deliver training programs to provide clinical training and education to EP physicians and lab staff as well as Affera employees. Mapping Specialist at Affera is a high visibility role where you will have direct exposure to key opinion leaders, and the opportunity to expand your set of experiences and broaden your impact. TCTMD All rights reserved. Bold thinking. The first patient was treated at New Yorks Mount Sinai Hospital by Vivek Reddy, who commented: SPHERE Per-AF introduces focal pulsed field ablation and is the first randomised catheter ablation IDE trial to treat persistent atrial fibrillation. Read More >> Arlington Capital Buys Millstone Medical Outsourcing . A streamlined workflow utilizing the sphere 9 catheter with its "trifecta" in the ability to perform an electro anatomical/activation map, and toggle between delivery of radiofrequency or pulsed field energy with the same catheter! Best, Netherlands. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. The company also announced that it closed a US$75M series C financing that will support the trial and continued development of Afferas platform. We have multiple positions and locations available. The investigational Affera technology is designed to provide solutions for patients with cardiac arrhythmias (irregular heartbeats) such as atrial fibrillation (AF). Competitive salary. We are developing a comprehensive, integrated platform that includes RF/PF ablation and mapping catheters, a mapping system, and an ablation system. Published content on this site is for information purposes and is not a substitute for professional medical advice. Newton, Circumferential ablation catheters, also known as single-shot catheters, have been developed to simplify the approach for PVI, allowing a rapid and effective ablation strategy that is particularly suitable for patients with paroxysmal atrial fibrillation, commented Dr. Elad Anter. Affera's Prism-1 cardiac mapping and navigation platform, Sphere-9 cardiac ablation catheter and investigational technologies are designed to enable the rapid creation of detailed maps used by. Designed to optimize procedural efficiency and efficacy across a broad range of cardiac arrhythmias, the Affera system has been used to treat over 275 patients. In everything we do, we are engineering the extraordinary. Driving factors for the acquisition 4. Gurleen Kaur, Medtronic to Acquire Affera : Expands cardiac ablation portfolio; first-time entry into mapping and navigation. For more information on Medtronic (NYSE:MDT), visit, Content for healthcare professionals only, Persistent Atrial Fibrillation Using Arctic Front Cardiac Cryoablation System. We have multiple positions and locations available. The Affera system is not currently approved for commercial use. Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide. The dilution was contemplated in the company's fiscal year 2023 adjusted earnings per share guidance that the company reiterated on August 23, 2022. "We're incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology; and now these new additions to our portfolio help support a leap forward in our commitment to build a comprehensive portfolio and help physicians achieve the best outcomes for patients. A valid Drivers License is required. The AFFERA system The AFFERA system uses a single lattice-tip catheter but two different energy generators, one for PFA and another for RF ablations. "This acquisition marks an important growth milestone for our cardiac ablation portfolio," saidRebeccaSeidel, president of the Cardiac Ablation Solutions (CAS) business, which is part of the Cardiovascular Portfolio at Medtronic. This role could be right for you if you are. using conventional electroanatomical mapping systems, - unipolar electrograms between a mapping electrode and a reference electrode (a surface electrode, wilsons central terminal or an independent electrode located in the ivc) - large far-field components, which often obscure a small local potential - bipolar electrograms provide more localized Enter the email you used to register to reset your password. The company also announced that it closed a US$75M series C financing that will support the trial and continued development of Affera's platform. The financing round adds Bain Capital Life Sciences and strategic investors to the slate of existing investors, who also participated in the round. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. A self-starter who performs well with autonomy, can be flexible in a dynamic work environment, and has a hunger for learning and building new skills. View the job description, responsibilities and qualifications for this position. This is a unique opportunity to join us early and have a direct impact on product roadmap, training, and the overall direction of our platform. We are developing a comprehensive, integrated platform that includes RF/PF ablation and mapping catheters, a mapping system, and an ablation system. Discussion Points: 1. including first-time entry into mapping and navigation, within one of the fastest growing medtech markets DUBLIN, Jan. 10, 2022 /PRNewswire/ -- Medtronic . ion Specialist - Boston at LightForce Ortho, Boston, MA, PuroClean Certified Restoration Specialist of Auburn, Framingham, MA. Affera is developing an integrated solution to efficiently deliver durable therapy for cardiac arrhythmia patients. Innovation of the Affera portfolio The primary role of the Mapping Specialist is to provide expert technical and clinical support and training to physicians and EP lab staff on the effective use of Affera's systems and catheters. The opinions expressed here are those of the interviewee and not necessarily of Radcliffe Cardiology. About. Piccini J: supported by R01AG074185 from the National Institutes of Aging; research . Affera is looking for a passionate, experienced, and self-starter Mapping Specialist to join our rapidly growing clinical team. The Affera system includes the Sphere-9 catheter and integrated Prism-1 mapping system to enable the rapid creation of detailed maps, as well as the versatile HexaGEN ablation system to deliver . WATERTOWN, MA Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today first-in-human use of its circumferential Pulmonary Vein Isolation (PVI) Pulsed Field Ablation (PFA) catheter, SpherePVI. Given the timing of today's closing announcement, this translates into approximately 3 to 4 cents in fiscal year 2023, approximately 5 cents in fiscal year 2024, and approximately 4 cents in fiscal year 2025. Minimum of a bachelors degree or 4 years of relevant professional work/military experience. A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI Catheter for treating paroxysmal AF. New data on the Medtronic Intrepid transcatheter mitral valve replacement (TMVR) system, including late-breaking results from the Intrepid Pilot Apreciat de Catalin Dragoe Affera's portfolio includes interventional solutions such as the Affera Prism-1 mapping and navigation platform, designed to help Copyright 2022. . Founded by leaders in the medical device industry, we are a highly selective team whose aim is to have a major impact on developing breakthrough, life-saving technologies. The catheter is integrated with the Affera system which includes the Prism-1 mapping and HexaGEN ablation system, as well as the Sphere9 focal ablation and mapping catheter. Free, fast and easy way find a job of 803.000+ postings in Bedford, MA and other big cities in USA. Support clinical trial activities including coordination with trial managers and study sites, system setup and testing, and mapping and ablation procedures. AF represents the largest disease segment, with nearly 60 million people affected worldwide. TCTMD is produced by the Cardiovascular Research Foundation (CRF). This new catheter complements the companys Sphere9, providing a complete range of tools for mapping, single-shot ablation for patient with paroxysmal atrial fibrillation, and focal ablation for patients with persistent atrial fibrillation, which often require tailored ablation with additional lesion sets. Affera, focused on developing comprehensive solutions for the electrophysiology market, offers superior focal and single-shot ablation options with integrated mapping. With an estimated 37 million people currently living with this condition, 1 in 4 adults over 40 is at risk of developing AFIB in their lifetime. Affera's product portfolio is not currently approved or available for sale or commercial use. This acquisition expands the company's cardiac ablation portfolio to include its first-ever cardiac mapping and navigation platform that encompasses a differentiated, fully integrated diagnostic, focal pulsed field and radiofrequency ablation solution. Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing cardiac arrhythmia market. The financing will enable us to execute the IDE trial, continue our development and clinical programmes, scale manufacturing and operations and build strong momentum moving forward.. TEL: +44 (0)20 7736 8788 Our Mission to alleviate pain, restore health, and extend life unites a global team of 95,000+ passionate people across 150 countries. "We're incredibly proud to have led the industry with the introduction of the proven safe and effective cryoablation technology; and now these new additions to our portfolio help support a leap forward in our commitment to build a comprehensive portfolio and help physicians achieve the best outcomes for patients.". Bolder actions. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. Actual Study Start Date : Jul 22, 2021. The work was conducted as part of a multi-center first-in-human study designed to evaluate the safety and effectiveness of the SpherePVI catheter and Affera system in patients suffering from atrial fibrillation (AFIB). 1. Excited to build and maintain advanced clinical knowledge of cardiac mapping and ablation, technical knowledge of the latest EP technology, and an understanding of the business landscape. The Affera full suite of solutions and technologies will complement the existing Medtronic atrial and ventricular arrhythmia disease management portfolio and support the company's efforts to offer differentiated, safe, and effective cardiac ablation solutions. We have multiple positions and locations available. Affera specialises in designing and manufacturing systems for cardiac mapping and navigation as well as catheter-based cardiac ablation technologies to treat cardiac arrhythmias such as atrial fibrillation (AF). Medtronic (NYSE:MDT) announced today that it agreed to acquire cardiac mapping and ablation technology developer Affera. 2. All rights reserved. Who are Affera, Inc. 's competitors? Medtronic to Buy Affera for Nearly $1B. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. AcQMap, AcQRef and AcQGuide devices are CE Marked and FDA cleared. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. We welcome our new investors and believe the round further validates the significant potential of our platform to address critical unmet needs within electrophysiology, commented Doron Harlev, CEO and founder of Affera. The SpherePVI enables performance of circumferential PVI with minimal catheter manipulation and lesion applications. "Our team designed the Affera platform with physicians and patients in mind, to advance the field of electrophysiology while supporting safe and efficient cardiac ablation procedures.". Maintain at least one of the following industry certifications: CEPS (IBHRE), RCES/RCIS. Competitive salary, 401k, generous medical coverage to suit yourneeds. 44 Pleasant St #200, Watertown, MA 02472, USA Affera is a venture-backed medical device company founded by a seasoned team of leaders in the industry. Deliver training programs to provide clinical training and education to EP physicians and lab staff as well as Affera employees. Through this acquisition Medtronic gains the Affera Prism-1 cardiac mapping and navigation platform, which will be compatible with Medtronic and multiple, competitive therapeutic catheters and technologies. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Real-world patient benefits of system Anticipated Primary Completion Date : Jul 22, 2022. Announces Successful First-In-Human Use of SpherePVI Circumferential Pulmonary Vein Isolation Device Using Pulsed Field Energy, Abbott Expands Its Medical Device Business with Acquisition In Catherter-Based Electrophysiology Market, Biosense Webster Launches CARTO 3 System CONFIDENSE Module for Optimized High-Density Mapping During Catheter Ablation Procedures, CABANA Misses Primary Endpoint, but Electrophysiologists See Support for Ablation, MedLumics Technology Validated for Real-time Assessment of Catheter Ablation Treatment of Atrial Fibrillation in Pre-clinical Feasibility Study, Miscellaneous Emerging Technologies 4: Stent-Based Pulmonary Vein Isolation Approach to Atrial Fibrillation, CardioFocus' HeartLight System Granted FDA Approval for Treatment of Atrial Fibrillation (AF). For more information, please visit www.affera.com. C) Salary.com using cookies (as described here) to refine and tailor the website visitor experience. ", Affera is a medical technology company dedicated to delivering unrivaled innovative solutions to address the rapidly growing demands for cardiac arrhythmia treatment. Almost one in 200 patients die early after AF ablation in Adagio Medical announces patient enrolment in PARALELL trial, Two decades of development in AF treatment and education, New data underpin drive towards earlier AF ablation strategies, Q-FFICIENCY trial shows promise for temperature-controlled ablation. Contribute to an innovative solution that can improve the lives of millions. The primary role of the Mapping Specialist is to provide expert technical and clinical support and training to physicians and EP lab staff on the effective use of Affera's systems and catheters during clinical procedures. By clicking Agree, I consent to our data usage policies as stated. The Affera system, SpherePVI and Sphere9 . Minimum of 3 years of Electrophysiology/Cath Lab or EP/Cardiovascular Device Industry experience. With an estimated $1B in annual revenue, the single-shot device segment has grown significantly over the last decade. About Affera. For more information, visitwww.affera.com. See my 2020 AF Symposium report: AcQ 3D Imaging . Medtronic has been a strategic investor in Affera through its minority investment portfolio and currently owns a 3% interest in the firm. Experience supporting clinical trial procedures is preferred. Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree") Description: SpherePVI Catheter with the Affera Mapping and Ablation System. TEL: +1 949 723 9309 Luke acts as Lexington Medical's Chief Patent Counsel. Ongoing SPHERE Per-AF trial Terms and Conditions | Privacy Policy. Strong sales professional with a BSc Honours focused in Sports and Exercise Science from University of Portsmouth. Medtronic to acquire Affera, a cardiac arrhythmia technology firm, for $925 million Affera makes cardiac mapping and navigation systems and catheter-based cardiac ablation technologies. Field Clinical Specialist in Electrophysiology. Copyright 2022 Radcliffe Medical Media. Aruna D Pradhan, Receive the the latest news, research, and presentations from major meetings right to your inbox. Please review the Instructions for Use for a complete listing of indications . He provides counsel on intellectual property related issues. Minimum of 3 years of Electrophysiology/Cath Lab or EP/Cardiovascular Device Industry experience. Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. 6. Skilled in Negotiation, Medical Devices, Sales, Working with Surgeons, and Management. The Affera system is not currently approved for commercial use. Anticipated Study Completion Date : Jul 22, 2023. A problem solver who can think critically in high pressure environments. Work on problems of diverse scope, engage in diagnostic dialog with internal and external stakeholders, and demonstrate sound judgment in selecting methods and techniques for solving problems. The Affera system includes the Sphere-9 catheter and integrated Prism-1 mapping system to enable the rapid creation of detailed maps, as well as the versatile HexaGEN ablation system to deliver either pulsed field or radiofrequency lesion sets in a variety of substrates. Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced that its platform was featured prominently in scientific sessions at the Heart Rhythm Society 2020 (HRS) meeting held online May 6-9. Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. Ability to sit for extended periods of time, working in a hospital laboratory setting, attending live patient cases, and wearing protective gear (e.g., lead apron). ACUTUS Medical combines their basket catheter non-contact mapping system (AcQ Mapping) with Pulsed Field ablation. multicenter, single-arm, clinical study of the Affera system (Affera, Inc., Watertown, Massachusetts) conducted at 3 centers in 2 European Union countries (2 centers in the . A problem solver who can think critically in high pressure environments. Develop relationships within and beyond the EP lab, including with physicians, nurses and technicians, and clinical and hospital administrators and staff, to drive awareness and usage of Afferas novel products. Experienced Account Manager with a demonstrated history of strategic and commercial wins in the medical device industry. Maintain at least one of the following industry certifications: CEPS (IBHRE), RCES/RCIS. Support clinical trial activities including coordination with trial managers and study sites, system setup and testing, and mapping and ablation procedures. Apply for the Job in Senior Signal Processing Engineer at Newton, MA. Treatment of Persistent Atrial Fibrillation With Sphere-9 Catheter and Affera Mapping and Ablation System. By Dan Niepow. Identify. Bright, motivated co-workers in a fun and collaborative office environment. We'll be sending you new jobs as they are posted. Able to take large amounts of data and translate information into actionable insights. A timely and effective written and verbal communicator with co-workers and all levels of the patient care team. Michelle O'Donoghue, The catheter is integrated with the Affera system which includes the Prism-1 mapping and HexaGEN ablation system, as well as the Sphere9 focal ablation and mapping catheter. No financial support was provided for the commissioning and publication of this interview. Remaining challenges for treating cardiac arrhythmias. Maintain composure and problem-solving focus during sometimes stressful interactions. On the comment by Doron Harlev, CEO of Affera, that the platform has a physician- and patient-centred design Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. Over the past 10 years, advances in cardiac mapping technology have provided improvements in stability, accuracy, speed and overall functionality. Nicolas M Van Mieghem, 155 North Wacker Drive, Suite 4250, Chicago, IL 60606 Mapping systems use mapping catheters to measure the electrical activity of cardiac tissue and create comprehensive three-dimensional electroanatomic mapping of your patients' hearts. On the comment by Doron Harlev, CEO of Affera, that. Acquisition adds mapping and navigation platform to company's cardiac ablation portfolio and brings an integrated system of diagnostic and therapeutic tools to address a broad spectrum of arrhythmias. January 11, 2022. 9 at the core of this technology is the lattice catheter, a 7.5fr bidirectional deflectable Affera is based in Newton, Massachusetts. Mapping Specialist Newton, Massachusetts, United States. Subjects will be randomly assigned 1:1 to receive treatment with either the Sphere-9 Mapping and Ablation Catheter and the Affera Mapping and Ablation System (investigational device) or the THERMOCOOL SMARTTOUCH SF radiofrequency ablation catheter (control device). Currently, the prevalence of cardiac arrhythmias including AF, supraventricular tachycardia (SVT), and ventricular tachycardia (VT), is increasing rapidly. The KODEX-EPD system is a completely new approach to cardiac imaging and mapping that has been developed to address key unmet needs in electrophysiology (EP) procedures today, offering a disruptive technology which will improve the efficiency and efficacy of life-saving cardiac . Ensure subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition. In everything we do, we are engineering the extraordinary. Excited to build and maintain advanced clinical knowledge of cardiac mapping and ablation, technical knowledge of the latest EP technology, and an understanding of the business landscape. . Affera, Inc. has raised $5M. This dual-generator design (radiofrequency or PF) permits switch-ing between RFA and PFA without removing the catheter or switching cables and allows utilization of a single electroana-tomic map. Verified employers. $103,263 to $134,255. This role could be right for you if you are, Receive alerts for other Mapping Specialist job openings, Salary.com Estimation for Mapping Specialist in Newton, MA. Affera is developing a comprehensive integrated platform to efficiently deliver durable therapy for a broad set of cardiac arrhythmia patients. The company continues to expect dilution of approximately 5 cents in both year 1 and year 2 and approximately 3 cents in year 3. Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures. Must be willing and able to travel up to 80% overnight locally, regionally, and nationally, sometimes on short notice. With its robust platform, clinical evidence, and product pipeline, Affera stands out in the rapidly growing electrophysiology segment, stated Jeffrey Schwartz, managing director at Bain Capital Life Sciences. As part of the closure, Medtronic will continue to support the SPHERE Per-AF Pivotal Trial. 7. . Affera designs and manufactures cardiac mapping and navigation systems and catheter-based cardiac ablation technologies, including a differentiated, focal pulsed field ablation solution, for. Developer of a medical device designed to treat heart rhythm disorders. Key Responsibilities PVI is the cornerstone of catheter ablation therapy for patients with atrial fibrillation. Jan 24, 2020. Learn under the guidance of some of the industry's prominent experts in the field of medical device engineering. It is not affiliated with or is an agent of, the Oxford Heart Centre, the John Radcliffe Hospital or the Oxford University Hospitals NHS Foundation Trust group. We are Medtronic. A timely and effective written and verbal communicator with co-workers and all levels of the patient care team. Product Highlights Bi-Directional tip deflection Thermocouple and Thermistor temperature monitoring capability Rotary dial designed for fine tip movements Extra lateral stability (XLS) incorporated at catheter tip Ergonomic handling Required Catheter Extension Cables - Page A.33 Abbott: A402580 STANDARD ABLATION CATHETERS. The Affera system and Sphere-9 catheter are. The company is developing an innovative system in the treatment of heart rhythm disorders, one of the fastest growing fields in medical devices. Email: [emailprotected] Affera, Inc. is a venture-backed medical device company dedicated to developing unrivaled solutions for the treatment of cardiac arrhythmia, a prevalent condition affecting millions of patients worldwide. B) Salary.com being able to use your name and address to tailor job posting to your geographic area. Full-time | Fully remote. This is a unique opportunity to join us early and have a direct impact on product roadmap, training, and the overall direction of our platform. Customer needs/requirements, and better outcomes for our world the financing round Bain Problem-Solving focus during sometimes stressful interactions you are interested in clinical training and education to physicians. Improve the lives of millions by clicking Agree, I consent to our real-time view, doctors able. Actionable insights CEPS ( IBHRE ), RCES/RCIS cardiac ablation portfolio ; first-time entry into mapping and ablation with. Device industry experience, policies, and procedures > Newton, Massachusetts, United States focal and single-shot ablation with. Puroclean Certified Restoration Specialist of Auburn, Framingham, MA Boston Scientific Corp for where he 23! Industry certifications: CEPS ( IBHRE ), visitwww.Medtronic.com 5 cents in year 3 Per-AF Pivotal.. 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