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Volta Medical’s AI based solution for patients in atrial fibrillation achieves robust validation in first peer-reviewed publication

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2 years ago

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  • Volta VX1 decision support software reproduces expert-physician electrogram (EGM) analysis that can assist physicians in the real-time identification of specific abnormal electrograms in a persistent atrial fibrillation (AF) population
  • After a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively
  • VX1 allowed for robust center-to-center standardization of identification of abnormal electrograms, confirming reproducibility of results across 8 centers and 17 operators
  • The Ev-AIFib study was an open-label single-arm uncontrolled study comparing the acute and long-term outcomes of 85 patients in persistent AF after ablation in regions exhibiting VX1-highlighted abnormal electrograms
  • The ongoing Tailored-AF randomized controlled trial is designed to demonstrate clinical significance and compare the outcomes of VX1-guided ablation versus standard ablation

MARSEILLE, France, Aug. 31, 2022 (GLOBE NEWSWIRE) — Volta Medical, a pioneering health tech company developing artificial intelligence (AI) software solutions to assist electrophysiologists to treat cardiac arrhythmias, today announced that the Journal of Cardiovascular Electrophysiology (JCE) has published peer-reviewed results from the Company’s successful Ev-AIFib-Proof-of-Concept-Study with VX1, an expertise-based AI software solution to assist operators in the real-time identification of specific abnormal electrograms (EGM) during atrial fibrillation (AF) procedures. The article titled “Artificial Intelligence Software Standardizes Electrogram-based Ablation Outcome for Persistent Atrial Fibrillation” is available at https://onlinelibrary.wiley.com/doi/abs/10.1111/jce.15657.

The study was the first large-scale clinical validation of a companion AI-based software solution that reproduces expert-physician electrogram (EGM) analysis and assists operators in the real-time identification of specific abnormal EGMs, known as dispersed EGMs, during ablation procedures in a persistent AF population. Results demonstrated that VX1 allowed for the building of standardized “Volta VX1 maps”, used as a reference for operators to conduct EGM-guided ablation. The standardization of the detection of abnormal EGMs facilitated a robust patient-to-patient and center-to-center uniformity in EGM-based ablation. No major differences between operator’s visual analysis and VX1 EGM maps were recorded, and there were no statistically significant differences between outcomes across the 8 study centers and 17 operators. Furthermore, after a one-year follow-up, patients demonstrated a high freedom from atrial fibrillation and from any atrial arrhythmia, 89% and 73% after an average of 1.3 procedures per patient, respectively. Also, notably there was acute AF termination of 88% for subjects in all centers.

“Catheter ablation is well-established as an important treatment for AF and is by far the most common cardiac ablation procedure performed worldwide. Due to the complexity of persistent AF, however, there is no uniform standard of care resulting in heterogenous approaches that yield mixed and often disappointing results associated with high recurrence rates,” said Jean-Paul Albenque, MD, Cardiac Electrophysiologist at the Clinique Pasteur, Toulouse, France, and co-author of the study. “Strategies using EGM assessment to guide ablation visually, rely heavily on the individual experience of the treating electrophysiologist to identify relevant areas making outcomes highly operator-dependent.”

With VX1, Volta has developed the first commercially available companion AI decision support software to assist operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial abnormal EGMs during atrial fibrillation or atrial tachycardia. The cutting-edge software solution uses machine learning including deep learning algorithms to detect abnormal signals and thus highlights potential regions of interest during AF ablation procedures. The system works in real time and identifies specific abnormal EGMs, known as dispersed EGMs.

Théophile Mohr Durdez, CEO and Co-Founder of Volta Medical, added: “The publication of these peer-reviewed trial results provides further validation of our approach – to leverage AI with cutting-edge software solutions and assist operators during cardiac ablation procedures. Over 1000 procedures have so far been supported in the EU and US by VX1 and based on clinician’s feedback and clinical results, we are confident that this approach will ultimately contribute to make ablation outcomes significantly more reliable.”

Based on these encouraging results, Volta Medical has initiated the TAILORED-AF trial, the first randomized controlled clinical trial to evaluate VX1-guided ablation compared to a ‘standard of care’ anatomical ablation approach. The aim of the study is to confirm the clinical significance of Volta Medical’s technology and lay the ground for establishing VX1 as a new standard of care for persistent AF ablation.

“The results of the Ev-AIFib trial show that Volta’s AI enhanced VX1 software is finally able to provide reliability and reproducibility in an EGM based approach – the holy grail of EGM based ablation approaches. The technology has shown a high potential to assist in treating the complex persistent AF patients,” said Prof. Dr. Isabel Deisenhofer, MD, head of electrophysiology at German Heart Centre Munich, and principial investigator of the international, multicenter TAILORED-AF trial. She continues: “In my experience, VX1 has been an extremely helpful tool, and I look forward to further explore and confirm the technology’s potential in the ongoing TAILORED-AF trial.”

About Ev-AIFib Trial
The EV-AIFib trial, a prospective, multicenter, non-randomized, study was designed to determine the feasibility and relevance of constructing standardized dispersion maps, so called ‘Volta VX1 maps’, to be used as a reference to operators conducting EGM-guided ablation of patients in persistent atrial fibrillation (AF), as well as the use of the VX1 technology for center-to-center standardization of dispersion mapping. In the trial physicians were provided with VX1 adjudications in real time and used their discretion to ablate where it was the most clinically relevant.

Carried out in 8 different centers with 17 participating operators, the study compared the acute and long-term outcomes of 85 patients after ablation in regions exhibiting dispersion between a primary and satellite centers. At the primary center, operators were the most experienced at dispersion-based ablation, while satellite centers corresponded to hospitals where physicians had little experience at performing dispersion-based ablation. The results were also compared to a control group in which dispersion-guided ablation was performed visually by trained operators.

About Atrial Fibrillation (AF)
AF can be considered an “electrical storm” in the atria in which all synchronized activities have disappeared, and the necessary coordination of the contraction stops. This can lead to a number of symptoms including palpitations, shortness of breath and in some patients, heart failure.

AF affects approximately 33 million patients worldwide – a figure expected to double by 2030 driven by an aging population.1   Evidence suggests a higher prevalence of AF in patients with hypertension, heart failure, coronary heart disease, obesity and diabetes. In addition, recent studies show that 20-30% of patients with ischemic stroke have had AF before, during or after the initial event. AF is also a major risk factor for stroke, increasing the likelihood of stroke by four to five times, as stagnant blood in the atrium during AF may lead to the formation of a clot, which can migrate to the brain. In addition, AF-induced strokes are associated with more severe damage.

Common treatment for AF includes medication that regulates or slows the heart rate.2 For patients who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, ablation is the current standard of care.2 Ablation uses heat or cold energy to create tiny scars in the heart to block abnormal electrical signals and restore a normal heartbeat.1 However, the efficacy of this approach depends to a large degree on the experience and intuition of the ablating physician.

About the Volta VX1 AI decision support software
VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and mapping technologies currently used in operating rooms or electrophysiology labs. VX1 is a medical device which is FDA cleared and has a CE mark. The FDA label reads, “The VX1 assists operators in the real-time annotation of 3D anatomical and electrical maps of human atria for the presence of multipolar intra-cardiac atrial EGMs exhibiting specific abnormal EGM, known as dispersion, during atrial fibrillation or atrial tachycardia. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial EGMs exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.”

About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a health tech company developing artificial intelligence software solutions to assist cardiac electrophysiologists during arrhythmia treatment procedures. Volta’s overarching goal is to drastically improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data with the highest standards of data protection. Its first product, VX1, a digital AI companion device and algorithm assists cardiologists for the real-time identification of specific abnormal EGMs, known as dispersed EGMs.

For more information, visit the company’s website at www.volta-medical.com.

Media Contacts

Volta Medical
Jeff Martin, VP of Global Marketing
[email protected]

U.S. Media Contact
FinnPartners
Glenn Silver
[email protected]

Europe Media Contact
MC Services AG
Julia Bittner
[email protected]

France Media Contact
Alize RP
Caroline Carmagnol
[email protected]

References

1 Chugh SS, Havmoeller R, Narayannan K, et al. Worldwide epidemiology of atrial fibrillation: A global burden of disease 2010 study. Circulation 2014; 129:837–8472
2 Mayo Clinic, Patient Care & Health Information, Tests & Procedures, Cardiac Ablation: https://www.mayoclinic.org/tests-procedures/cardiac-ablation/about/pac-20384993

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Department of Health – Abu Dhabi Unveils ‘Declaration of Principles’ on Bioconvergence to Enhance Global Healthcare Outcomes

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May 13, 2024

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ABU DHABI, UAE, May 13, 2024 /PRNewswire/ — An an outcome of the Health Leaders Forum (HLF) organised during Abu Dhabi Global Healthcare Week (ADGHW), the Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate, unveiled a Declaration of Principles on Bioconvergence, to transform healthcare, improve human health and well-being. As a first-of-its-kind initiative, the Declaration outlines global principles covering guidance on transparency, accountability, and bias mitigation, as well as research ethics and ethical decision-making in the field of Bioconvergence.

Bioconvergence has been recognised as the latest technological trend of the 21st century for the healthcare sector. It is a transdisciplinary field that merges engineering and life sciences, and is set to revolutionise the health-tech industry. Bioconvergence fuses life sciences with a vast number of technologies from fields such as mathematics, engineering, and physical and computational sciences.
The Declaration of Principles will witness leading local and global entities collaborate with DoH including Amazon, Microsoft, UAE University (UAEU), Mohammad Bin Zayed University for AI (MBZUAI), Core 42 and Masdar City. Segmented into six strategic pillars, the principles aim to advance Bioconvergence research and development, encourage investment in the field to address urgent healthcare challenges, establish international cooperation frameworks, prioritise research areas in public health and personalised medicine, and promote the adoption of advanced technologies such as Artificial Intelligence (AI) and nanomedicine.
Dr. Asma Ibrahim Al Mannaei, the Executive Director of the Research and Innovation Centre at the Department of Health – Abu Dhabi (DoH): “In the intricacies of Bioconvergence, establishing fundamental principles is not merely a choice, but a collective responsibility. These principles serve as a beacon of transparency, guardians of accountability and shields against any form of bias. With the ever-evolving intersection of health and technology, integrity and diligence remain guiding threads for the Department of Health – Abu Dhabi. Reinforcing Abu Dhabi’s position as a leading destination for innovation in healthcare, the unique Declaration serves as a testament to the Department’s continued efforts to build a healthier world and shape the future of healthcare for generations to come.”
Moreover, upholding ethical standards and responsible practices involve raising awareness on the benefits and risks of Bioconvergence technologies, establishing ethical guidelines, and ensuring accessibility and affordability for all. Investment in education and workforce development entails supporting skill development, integrating Bioconvergence into relevant curricula, fostering interdisciplinary collaboration, and promoting diversity in the field.
Additionally, fostering collaboration and the exchange of knowledge among stakeholders, advocating for supportive policies and regulations, and engaging the community through awareness campaigns and transparent communication are crucial steps in advancing Bioconvergence research and innovation while maintaining community’s trust and support. These key pillars will support accelerating the future of healthcare and life sciences by making quality health a global priority.
Held under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of Abu Dhabi Executive Council, Abu Dhabi Global Healthcare Week is a major government initiative taking place between 13 and 15 May 2024. ADGHW seeks to accelerate collaboration, innovation, and investment, and bring together researchers, policymakers, healthcare specialists, investors, and entrepreneurs across the global healthcare and life science ecosystem.
For more information please visit: https://www.adghw.com/
About Department of Health – Abu Dhabi (DoH):
The DoH is the regulatory body of the healthcare sector at the Emirate of Abu Dhabi and ensures excellence in healthcare by monitoring the health status of the population. DoH defines the strategy for the health system, monitors and analyses the health status of the population and performance of the system. In addition, DoH shapes the regulatory framework for the health system, inspects against regulations, enforce standards, and encourages adoption of world-class best practices and performance targets by all healthcare service providers in the Emirate. DoH also drives programmes to increase awareness and adoption of healthy living standards among the residents of the Emirate of Abu Dhabi in addition to regulating scope of services, premiums and reimbursement rates of the health system.
For further information on DoH, visit https://www.doh.gov.ae/ and follow on X, Instagram, Facebook, LinkedIn and YouTube.
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Advanced HPC Server Platforms by MiTAC and TYAN Spotlighted at ISC High Performance 2024

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May 13, 2024

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HAMBURG, Germany, May 13, 2024 /PRNewswire/ — Today, the subsidiary of MiTAC Holdings Corp.(TSE:3706), MiTAC Computing Technology and its server brand TYAN®, the leading manufacturer in server platform design worldwide, bring their new server platforms to the ISC 2024 event, booth #B01 in Hamburg, Germany. These solutions harness the power of the latest AMD EPYC 9004 series and AMD Ryzen 7000 series, along with the 5th Gen Intel Xeon Scalable Processors, offering optimized performance for HPC needs.

MiTAC introduces its revolutionary lineup of DSG products
Driven by shared values, MiTAC and Intel have had a strong partnership for years. Last year, MiTAC took over the manufacturing and sales of products designed by Intel Datacenter Solution Group (DSG). Today, MiTAC presents two models from its DSG product lineups, which are from the Intel Server M50FCP Family and the Intel Server D50DNP Family, at ISC 2024.
First, MiTAC displays a multi-node server, the Intel Server System D50DNP1MHEVAC 1U Half-Width air-cooled compute module with EVAC heatsink from the Intel Server D50DNP Family (Denali Pass). Intel® Server D50DNP family is the highest-performance density server featuring 5th/4th Gen Intel® Xeon® Scalable Processors or the Intel® Xeon® CPU Max Series and purpose-built modules, delivering robust performance, efficiency, and scalability tailored to specific needs for AI computing.
Then, there is the 1U Intel Server System M50FCP1UR204 from the Intel Server M50FCP Family (Fox Creek Pass). Supporting 5th/4th Gen Intel® Xeon® Scalable processors, the general purpose Intel® Server M50FCP Family offers robust compute capabilities, integrated accelerators, and exceptional I/O and memory bandwidth, making it the perfect solution for handling data-intensive mainstream tasks.
TYAN brings HPC optimized servers at ISC 2024
The Transport CX TD76-B8058 is a 2U 4-node single-socket HCI server powered by AMD EPYC 9004 processors. Each node includes 16 DDR5-4800 DIMM slots, 4 hot-swappable E1.s drive bays, 2 NVMe M.2 slots, 1 OCP v3.0 LAN mezzanine slot, and 1 standard PCIe 5.0 x16 slot. Front I/O facilitates efficient network cable routing, while rear-accessible hot-swappable cooling fans and redundant 80+ Titanium power supplies ensure optimal system serviceability.  Powered by 5th/4th Gen Intel Xeon Scalable processor, TYAN Thunder CX TD76-B5658 is a 2U 4 nodes single-socket server designed for high-density cloud server deployment. It comes with shared system fans, redundant 80+ Titanium power supplies, and hot-swappable modules for simple maintenance. Additionally, it offers front I/O for effortless network cable management, and each node supports PCIe 5.0 x16, OCP v3.0 LAN mezzanine, and NVMe E1.s SSDs.
Apart from the above, TYAN provides the Transport CX GX40-B8016 for those requiring entry-level servers. This compact 1U AMD Ryzen cloud server is perfect for front-end portal and edge computing tasks in data centers. It features 4 DDR5-4800 UDIMM slots, supports up to 4 SATA drives, 2 NVMe M.2 slots, and one PCIe 5.0 x16 slot.
About MiTAC Computing Technology Corp.
MiTAC Computing Technology Corp, a MiTAC Holdings Corp. (TSE:3706) subsidiary, specializes in cloud and edge computing solutions and has over 30 years of design and manufacturing expertise. With a strong focus on large-scale data centers, the company offers flexible and customized supply models for various systems and applications. Its product lineup includes TYAN servers, 5G ORAN servers, high-performance AI servers, and data center products. Intel Datacenter Solutions Group (DSG) transited its business to MiTAC since July 2023, allowing MiTAC expanding its product offerings with cutting-edge total cost of ownership solutions for next-gen data center equipment.
MiTAC Computing Technology Official website: www.mitacmct.com
MiTAC DSG website: https://datacentersolutions.mitacmct.com/
About TYAN
TYAN, as a leading server brand of MiTAC Computing Technology Corporation under the MiTAC Holdings Corp. (TSE:3706), designs, manufactures and markets advanced x86 and x86-64 server/workstation board technology, platforms and server solution products. Its products are sold to OEMs, VARs, System Integrators and Resellers worldwide for a wide range of applications. TYAN enables its customers to be technology leaders by providing scalable, highly-integrated, and reliable products for a wide range of applications such as server appliances and solutions for HPC, hyper-scale/data center, server storage, AI and security appliance markets. For more information, please visit TYAN’s website at http://www.tyan.com or MiTAC Computing Technology Corporation website at http://www.mitacmct.com
AMD, the AMD Arrow logo, EPYC, Ryzen and combinations thereof are trademarks of Advanced Micro Devices, Inc.
Intel, the Intel logo, Xeon and combinations thereof are trademarks of Intel Corporation
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Department of Health – Abu Dhabi partners with MBZUAI and Core42 to launch Global AI Healthcare Academy

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May 13, 2024

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ABU DHABI, UAE, May 13, 2024 /PRNewswire/ — The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate, signed a Memorandum of Understanding (MoU) with Mohamed bin Zayed University of Artificial Intelligence (MBZUAI), the leading AI research-based academic institution located in Abu Dhabi, and Core42, a G42 company offering AI solutions, during Abu Dhabi Global Healthcare Week (ADGHW). This MoU will launch the global AI Healthcare Academy to the health workforce. The MoU was signed by Dr. Rashed Obaid Al Suwaidi, Executive Director of Healthcare Workforce Planning Sector at DoH, Sultan Al Hajji, Vice President of Public Affairs and Alumni Relations at MBZUAI and Talal Al Kaissi, Executive Vice President, Chief Product and Global Partnership Officer at Core42.

 
 
Reinforcing Abu Dhabi’s position as a leading destination for healthcare and life sciences, the partnership seeks to establish a framework of collaboration to strengthen the Emirate’s position at the forefront of technology-enabled and data-driven healthcare systems. The new AI Healthcare Academy will help to build a global AI-trained workforce, which is capable of advancing diagnostic and operational efficiency, significantly improving patient care, and streamlining healthcare processes around the world.
Sultan Al Hajji, Vice President of Public Affairs and Alumni Relations at MBZUAI, said: “Healthcare is a key research pillar for MBZUAI, because we recognise the transformative and life-saving potential of AI across a wide range of diagnostic and treatment areas. In addition to our recent effort in establishing the Institute of Digital Public Health, we are proud to partner with The Department of Health – Abu Dhabi in launching the new AI Healthcare Academy. MBZUAI will provide the Academy our world-class faculty to facilitate AI workshops and training to upskill the healthcare workforce in support of the UAE leadership’s vision to become a global hub for AI and a centre for life sciences.”
Through leveraging advanced technologies and harnessing the power of AI, DoH seeks to upskill the health workforce, enhance local practices and contribute to broader medical research and treatment modalities worldwide. By embracing AI-driven technologies, healthcare professionals can stay at the forefront of innovation, fostering collaboration and knowledge exchange on a global scale.
By collaborating with MBZUAI through its Institute of Digital Public Health, the Academy will encompass ground-breaking research. These efforts will encourage public-private partnerships, fostering collaboration to secure ample funding and ensure ongoing sustainability, setting the academy for long-term success and supporting responsible and impactful innovation.
Under the patronage of His Highness Sheikh Khaled bin Mohamed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Chairman of Abu Dhabi Executive Council, Abu Dhabi Global Healthcare Week (ADGHW) is a major government initiative from DoH, taking place between 13 and 15 May 2024.
For more information please visit: https://www.adghw.com/
About Department of Health – Abu Dhabi (DoH):
The DoH is the regulatory body of the healthcare sector at the Emirate of Abu Dhabi and ensures excellence in healthcare by monitoring the health status of the population. DoH defines the strategy for the health system, monitors and analyses the health status of the population and performance of the system. In addition, DoH shapes the regulatory framework for the health system, inspects against regulations, enforce standards, and encourages adoption of world-class best practices and performance targets by all healthcare service providers in the Emirate. DoH also drives programmes to increase awareness and adoption of healthy living standards among the residents of the Emirate of Abu Dhabi in addition to regulating scope of services, premiums and reimbursement rates of the health system.
For further information on DoH, visit https://www.doh.gov.ae/ and follow on X, Instagram, Facebook, LinkedIn and YouTube.
About Mohamed bin Zayed University of Artificial Intelligence (MBZUAI)
MBZUAI is a graduate, research university focused on artificial intelligence, computer science, and digital technologies across industrial sectors. The university aims to empower students, businesses, and governments to advance artificial intelligence as a global force for positive progress. MBZUAI offers various graduate programs designed to pursue advanced, specialized knowledge and skills in artificial intelligence, including computer science, computer vision, machine learning, natural language processing, and robotics. For more information, please visit www.mbzuai.ac.ae.
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