About Volta
Non Dispersed Electrocardiograms
Dispersed Electrocardiograms
1
dispersion location
Multipolar electrogram abnormality associated with the perpetuation of atrial fibrillation. Red: highly dispersed electrograms, Orange: dispersed electrograms, Blue: non-dispersed electrograms.
2
mapping catheter
Steerable, multipolar electrode catheter. Allows for the recording of the local electrical activity.
3
reference cycle length
Atrial cycle length estimated from recordings obtained with the coronary sinus catheter.
4
mapping cycle length
Local cycle length estimated from real-time recordings obtained with the mapping catheter.
1
dispersion location
Multipolar electrogram abnormality associated with the perpetuation of atrial fibrillation. Red: highly dispersed electrograms, Orange: dispersed electrograms, Blue: non-dispersed electrograms.
2
mapping catheter
Steerable, multipolar electrode catheter. Allows for the recording of the local electrical activity.
3
reference cycle length
Atrial cycle length estimated from recordings obtained with the coronary sinus catheter.
4
mapping cycle length
Local cycle length estimated from real-time recordings obtained with the mapping catheter.
Compliance
Patient privacy: All data collected is anonymized or pseudonymized in compliance with Data Protection regulations. Notably, data undergoes a state-of-the-art encryption (dual process, dual keys). Our policy meets the highest standards of data protection.
CE marked & FDA cleared: Volta’s VX1 software solution is the first AI-based solution in the interventional cardiology space to have obtained FDA clearance and CE marking.
Technology
Real time analysis: VX1 provides state-of-the-art analysis in real-time, ensuring optimal usability.
Precision: its integration allows for high density mapping in both atria.
Intellectual Property: Volta’s technology is protected internationally with multiple patents.
Data Driven: VX1 algorithm has been trained on large, carefully curated databases. Our goal is to mimic the expertise of trained physicians and reduce inter-operator variability in identifying specific abnormal electrograms.
Compatibility
Most multipolar mapping catheters
Two EP recording systems
Most 3D navigation systems
VX1. vs. Trained Expert Cardiac Electrophysiologists
Conclusions
SOURCE: HRS 2020 Imagineer Tech Showcase.
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The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion
for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.
Our team
Management
Team
Théophile Mohr Durdez
CEO, co-founder
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Théophile Mohr Durdez
CEO, co-founder
Théophile grew up in France, Germany and Austria. Since his young age, he wanted to help his fellow humans with technology. Latter on, he studied at Ecole polytechnique (Paris), where he fell in love with Statistics, Machine and Deep Learning. There, he obtained a double degree with the Business School HEC (Paris).
His first accomplishment was to create a wheelchair controlled via eye-tracking for SLA disabled people. He then helped in solving complex geophysics with the use of differential equations.
In 2016, he co-founded Volta, where he was the passionate architect and inventor of Volta’s algorithms. In 2017, Théophile received the Research Award from Ecole polytechnique for the algorithms that he developed at Volta.
Théophile is hiring and leading a team of top-talents to drive Volta towards success by making a difference for operators and patients.
Julien Seitz
President, co-founder
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Julien Seitz
President, co-founder
Julien is the acting Chief of the cardiac electrophysiology section at Saint Joseph Hospital (Marseille, France).
St-Joseph hospital is one of the three highest-volume ablation center in the country. This gave him many opportunities to think deep about what interventional cardiologists need most. Julien is well-known for his contributions to the field of electrogram-based ablation. He has published plenty of manuscripts in high-impact cardiology journals. He is a regular guest speaker, chairman at major conferences.
Since he started as an interventional cardiologist, Julien has been obsessed with making accessible any complex ablation approach to large numbers of colleague physicians. He started with conceptualizing multipolar-electrogram visual interpretation into a series of simple steps.
Since Volta was created, he used his in-depth experience to help design AI algorithms that provide simple but powerful cues to cardiologists.
Jérome Kalifa
Chairman, CMO, co-founder
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Jérome Kalifa
Chairman, CMO, co-founder
Both basic scientist and clinical electrophysiologist, Jérôme is based in the USA and currently Faculty at Brown University, Rhode Island, USA.
Jérôme dedicated about two decades to translational and clinical research in cardiac electrophysiology.
He is a seasoned speaker, chairman and reviewer for cardiology journals and conferences. His research effort has focused on understanding atrial fibrillation mechanisms as they pertain to cardiac interventions.
His background in cardiac mapping, imaging, database management and catheter technologies helped us design Volta’s algorithms.
Jérôme’s knowledge of the US clinical landscape is helping Volta address the needs of US users.
Laurent Launay
VP Engineering
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Laurent Launay
VP Engineering
Ph.D. in Computer Science
24+ years of experience in GE Healthcare and IRT b-com
Worked as Senior Manager for 3D applications, workstations applications and platforms
John Slump
CFO
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John Slump
CFO
Founder/CFO of multiple med-tech companies including FARAPULSE acquired by Boston Scientific Experienced medical devices & health tech operator
Raised >$100M of total startup financing and returned >$500M of exit value to shareholders with an attractive ROI
Jeff Martin
VP of Global Marketing
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Jeff Martin
VP of Global Marketing
20 years of experience in med device marketing.
Previously Marketing Director at Acutus; Group Product Director at Biosense Webster.
Highly effective in development and execution of global strategic marketing/field team plans.
El Makki Voundy
Full-Stack Developer
Fabienne Pouplier
DPO
Mohsen Shah
Director of US Operations
Daniel Guerrero
US Clinical Operations Manager
Didier Villevalois
Full-Stack Developer
Philippe Tartaise
Software Engineering Manager
Clément Bars
VP, co-founder
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Clément Bars
VP, co-founder
Clément has devoted his career to refining his understanding of procedural work flows in the field of cardiovascular electrophysiology.
Clement has become a well-known expert at simplifying work flows, specifically as they pertain to atrial fibrillation catheter ablation. His many contributions to the field of ablation could be summarized as “Do what you understand well, but keep it simple”.
He is regularly invited as a guest speaker or as a proctor in major hospitals in Europe, USA and Asia.
At Volta, he oversees the clinical evaluation of Volta’s algorithms. With more than 40 cardiac electrophysiologists visiting us last year alone, Clément has formed a large network of interventional cardiologists that cannot wait to try Volta’s algorithms.
Sabrina Siame
Clinical Research Assistant
Aman
Business Analyst
Loren Siry
HR Manager
Dinara Veshchezerova
Data Scientist
Mélanie Reist
Field Technical Engineer
Meryem Serdi
Field Technical Engineer
Maxime Basset
Field Technical Engineer
Paola Milpied
VP Clinical & Regulatory Affairs
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Paola Milpied
VP Clinical & Regulatory Affairs
Paola is a former engineer and data scientist who holds a PhD in signal processing and machine learning applied to Cardiology. She has 13+ years of experience in medical device companies in France and in the US where she held several roles in clinical research and regulatory affairs in the cardiovascular field.
At Volta, Paola leads the clinical, quality and regulatory affairs department with an ambitious clinical program as well as major regulatory challenges.
Yoann Dutil
QMS Compliance Manager
Audrey Balzano
Executive Assistant
Thomas Boudou
Data Scientist
Camille Schmisser
Clinical & Regulatory Affairs Specialist
Idriss Lopes Sanches
Full Stack Developer
Aurélien Rosiau
Full-Stack Developer
Vianney Guesdon-Vennerie
Front-End Developer
Denis Hansjacob
COO
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Denis Hansjacob
COO
After more than 30 years as a high-level executive in the Biomedical Device Industry, Denis decided to join Volta to be part of the next wave of technology designed for the operating room.
Denis has been Managing Director of St. Jude Medical France and Vice-President for Northern Europe, where he led commercial operations. He has a unique understanding of marketing, sales and reimbursement mechanisms. Denis is helping Volta’s products spread quickly in Europe and the USA.
Also, Denis is shaping the future of biomedical devices revenue model. Denis is the proponent that AI is the best solution to cure more patients from AF in the best cost efficient way.
Anthony Appetiti
Head of Sales EU
Rebecca Sircoulomb
Head of product
Investors & Partners
Press releases
First U.S. patients with persistent cardiac arrythmias treated using Volta Medical’s artificial intelligence-based analysis
First U.S. patients with persistent cardiac arrythmias treated using Volta Medical’s artificial intelligence-based analysis
Novel, FDA-cleared and CE-certified medical device is designed to help cardiologists identify cardiac abnormalities in patients undergoing ablation treatment for persistent, drug-resistant atrial fibrillation (AF), a common heart condition.
New York-Presbyterian Queens, Northwell Health’s Lenox Hill Hospital, New York City, and Ascension St. Vincent’s Riverside, Jacksonville, Fla. are the first U.S. medical centers to use Volta’s VX1 product. All three are participating in an international, randomized, controlled clinical trial to evaluate the outcomes of VX1-guided ablation versus standard ablation. They are actively recruiting patients for the trials.
Marseille, France and Providence, Rhode Island, USA December 21, 2021 – Volta Medical, a pioneering health tech company developing artificial intelligence (AI)-based software solutions to treat cardiac arrythmias, today announced the introduction of its leading-edge product, VX1, at three leading U.S. hospitals. New York Presbyterian Queens, Northwell Health’s Lenox Hill Hospital both in New York City, and Ascension St. Vincent’s Riverside, Jacksonville, Fla., are the first U.S. hospitals to implement VX1, which is designed to improve outcomes for patients undergoing atrial fibrillation (AF) ablation procedures.
All three hospitals also are recruiting AF ablation patients to participate in an international, randomized controlled clinical trial to evaluate the outcomes of VX1-guided ablation versus standard ablation. VX1 is cleared as a medical device by the U.S. Food and Drug Administration and CE-certified by the European Union.
VX1 is the first commercially available AI software to help clinicians combat high failure rates in the use of ablation for treating persistent, drug-resistant AF. AF, characterized by an irregular and chaotic heartbeat (cardiac arrythmia), can lead to more serious health issues such as heart failure and stroke. During AF ablation, a specialized cardiologist known as an electrophysiologist inserts catheters through the blood vessels into the heart to burn or freeze that tissue that is causing abnormal electrical signals in the upper chamber, or atrium. The procedure creates scarring that restores a normal heartbeat.
The VX1 system analyzes electrical signals measured during the procedure and identifies abnormalities in real-time. VX1 is versatile and can be installed in most operating rooms and is compatible with the main multipolar catheters and mapping systems.
“We are excited by the potential this approach has to help our patients who are living with persistent, drug-resistant AF,” says Seth Goldbarg, MD, Director of Cardiac Electrophysiology at New York-Presbyterian Queens and assistant professor of clinical medicine at Weill Cornell Medicine. “The VX1 system may help us tailor our procedures for each patient by more precisely pinpointing optimal ablation locations in real time.”
“To date, electrophysiologists have relied on their own experience and on simple analysis tools to make decisions about ablation locations as opposed to using robust measurable electrical abnormalities,” said Théophile Mohr Durdez, CEO and Co-Founder of Volta Medical. “To date, we have supported approximately 500 procedures with our AI-based analysis and the feedback has been excellent. We are very confident that this approach can help revolutionize the field and prove to significantly improve patient outcomes.”
Toward that end, Volta Medical has initiated the TAILORED-AF trial, the first randomized controlled clinical trial to evaluate VX1-guided ablation compared to conventional anatomical ablation approaches. The international, multi-center trial will involve 25 sites and 342 patients and is expected to report results in 2024.
“Treating the large number of patients with severe forms of drug-resistant, persistent AF remains an ongoing challenge for clinicians because current therapeutic strategies cannot offer predictable efficacy,” said Stavros Mountantonakis, MD, Director of Cardiac Electrophysiology at Lenox Hill Hospital, part of Northwell Health. “We’re finding VX1 to be a valuable tool in our ablation procedures, and we’re hopeful that the TAILORED-AF trial will validate its use as a game-changing innovation in ensuring improved, long-term results for these patients.”
“Our patients with drug-resistant, persistent AF face many ongoing challenges, and we’re pleased to be offering the VX1 system as a promising new treatment strategy for their ablation procedures,” said Saumil R. Oza, MD, a cardiologist with Ascension St. Vincent’s Riverside in Jacksonville, Fla. “Current ablation techniques cannot offer predictable efficacy, which is why the VX1 system holds so much promise. Because it enables us to precisely pinpoint optimal ablation locations for each patient, we are confident that it will lead to better treatment outcomes.”
Dr. Seth Goldbarg receives compensation in his role on the scientific advisory board for Volta Medical and the steering committee for the Tailored AF Trial. Dr. Goldbarg also owns shares in Volta Medical.
About Atrial Fibrillation (AF)
An estimated 6.1 million people in the United States have AF with projections to reach nearly 12.1 million in 2030.4,5 Worldwide, it affects more than 33 million people.1 Symptoms include palpitations, lightheadedness and shortness of breath. In some patients, AF can lead to heart failure. AF is not only an extremely costly public health issue but also a major risk factor for stroke, posing a 4-to-5 times greater risk than for the general population.6 AF is commonly treated with medication that regulates or slows the heart rate.2 For patients who cannot tolerate or 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. However, the efficacy of this approach depends largely on the experience and intuition of the electrophysiologist. With 50% of persistent AF patients requiring repeat treatments,7 the need for more precise therapies is significant.
About the TAILORED-AF trial
TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1 AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy targeting PVI alone for the treatment of persistent AF. The primary endpoint of the study is the absence of documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12-month period, following one or more procedures, as well as safety. Volta Medical expects results from the TAILORED-AF trial in 2024.
For more information about participating in the TAILORED-AF trial, contact Dan Guerrero daniel.guerrero@volta-medical.com.
About Volta Medical
Volta Medical is a health tech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta’s overarching goal is to significantly improve cardiac arrythmia management by developing state-of-the-art, data-driven medical devices based on large databases of procedural data with the highest standards of data protection. Founded by three physicians and a data scientist in 2016 in Marseille, France, Volta’s first product, VX1, assists cardiologists in the real-time identification of specific abnormal electrograms, known as dispersed electrograms. For more information, visit the company’s website at www.volta-medical.com.
Media Contacts United States
Glenn Silver
Lazar-FINN Partners
glenn.silver@finnpartners.com
(973) 818-8198
Volta Medical raises 23 million Euros to revolutionize persistent AF ablation
Volta Medical raises 23 million Euros to revolutionize persistent AF ablation
Marseille, 7 January 2021 – Volta Medical, a pioneering French-based HealthTech startup, working on novel artificial intelligence (AI) algorithms to treat cardiac arrythmias, today announced that it has successfully raised 23 million Euros. The financing round was led by Gilde Healthcare with participation of existing shareholder Pasteur Mutualité. The new capital will allow the company to establish its revolutionary FDA-cleared and CE marked VX1 AI software solution as a new standard of care, pursue further R&D activities and start to roll out commercial activities across the US and Europe. Recruitment for TAILORED-AF, an international multicenter trial has already started. Volta Medical will be welcoming two new Board members. Janke Dittmer, General Partner at Gilde Healthcare, has been nominated as a board member and former medical device industry top executive, Denis Gestin, as an independent board member.
After developing the first commercially available AI software to help electrophysiologists improve management of cardiac arrythmias, Volta Medical is now preparing to transform the way ablation procedures will take place in the future. Theophile Mohr-Durdez, CEO and co-founder of Volta Medical mentioned: “We are excited to be able to complete our highly ambitious medical program with the start of TAILORED-AF, a new randomized controlled trial (RCT). This trial aims to demonstrate how our AI software can help physicians optimize both efficacy and efficiency when performing complex procedures to treat heart rhythm disturbances.” Atrial fibrillation (AF) currently affects over 30 million patients worldwide. This underlines the importance of the TAILORED-AF trial which is likely to result in a breakthrough approach for tackling one of the world’s greatest public health challenges in a more consistent and reproducible manner. According to Gilde Healthcare’s Janke Dittmer, “We are excited to support Volta’s team in bringing a unique solution to address one of the biggest unmet needs in the large and fast-growing electrophysiology market”.
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 is also a major risk factor for stroke, as stagnant blood in the atrium during AF may lead the formation of a clot, that can migrate to the brain. AF increases the likelihood of stroke by four to five times and AFib-induced strokes that are generally associated with more severe damage.
AF is an extremely costly public health problem. It affected approximately 6 million patients in the US in 2019 and 11 million patients in Europe in 2018 and prevalence is estimated to double by 2060. In Europe 120,000-215,000 new cases are projected to occur each year reaching a total AF patient population prevalence of 14-17 million by 2030. Evidence suggests a higher prevalence of AF in patients with hypertension, heart failure, coronary heart disease, obesity, diabetes. In addition, recent studies show that 20-30% of patients with ischemic stroke have had AF before, during or after the initial event.
The TAILORED-AF trial
TAILORED-AF is an international, multicenter trial designed to compare the VX1 AI software ablation strategy with currently used conventional anatomical ablation approaches. According to Dr Tom De Potter, Head of Electrophysiology, OLV Hospital, Aalst, Belgium and one of the TAILORED-AF trial investigators, “treatment of the more severe forms of drug-resistant persistent AF remains a major challenge in our field, both due to the large number of patients affected and lack of therapeutic strategies that can offer predictable efficacy. Thanks to the software’s ability to identify signals that are relevant, from those that are less relevant, one of its greatest and most unique benefits is to allow for a more easily reproducible approach to ablation.” The results of the Ev-AIAFIB proof of concept study carried out with VX1 in 8 different centers will soon be published. They will provide data on why and how this new approach has the potential to provide electrophysiologists with a guidance tool that will optimize treatment of patients with AF in a lasting manner.
Conventional ablation methods, while useful for treating patients, who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, have so far been less precise than desired. Their results, even if significant in certain cases, remain sub-optimal. Localization and ablation of drivers perpetuating AF have been at the forefront of cardiovascular disease research but have not led to any radical changes to-date. Volta’s system is intuitive, user-friendly and shows promise to potentially reduce inter-operator variability in the analysis of procedural data without lengthening either the diagnostic or therapeutic procedures. “We are eager to help new centers access and use our revolutionary tool during ablation procedures. This cutting-edge medical innovation enhances the efficiency and precision of the practitioners who are analyzing real-time data in the operating room. Its robustness will help physicians adopt a more efficient workflow and take the right decisions” – claimed physician co-founder, Jerome Kalifa.
About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a HealthTech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta’s overarching goal is to drastically improve cardiac arrythmia management by developing state-of-the-art, data-driven medical devices based on large databases of procedural data with the highest standards of data protection. Its first product, VX1, assists cardiologists for the real-time identification of specific abnormal electrograms, known as dispersed electrograms.
For more information, visit the company’s website at www.volta-medical.com.
About the VX1 AI software
VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and technologies currently used in operating rooms or electrophysiology labs. The VX1 software analyzes the patient’s electrograms in real-time to identify specific electrograms known as dispersed electrograms. It also provides a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters.
The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.
VX1 is a medical device which is FDA cleared and has a CE mark.
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor managing over €1.4 billion across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in fast growing companies active in digital health, MedTech and therapeutics. The venture & growth companies are based in Europe and North America. For more information, visit the company’s website at www.gildehealthcare.com.
Media Contacts
BCW agency
Linda Pavy – Tel: +33 (0)6 07 59 43 95 – Email: linda.pavy@bcw-global.com
Maëly Daviles – Tel: +33 (0)6 13 20 51 02 – Email: maely.daviles@bcw-global.com
Pauline Coudert – Tel +33 (0)6 88 38 46 58 – Email: pauline.coudert@bcw
References
1.https://globalheartjournal.com/articles/abstract/10.1016/j.gheart.2014.01.004/
2.https://www.ahajournals.org/doi/10.1161/strokeaha.115.012004
3.https://pubmed.ncbi.nlm.nih.gov/14966048/
4.Marco V. Perez, M.D., Kenneth W. Mahaffey, M.D., Haley Hedlin, Ph.D., John S. Rumsfeld, M.D., Ph.D., Ariadna Garcia, M.S., Todd Ferris, M.D., Vidhya Balasubramanian, M.S., Andrea M. Russo, M.D., Amol Rajmane, M.D., Lauren Cheung, M.D., Grace Hung, M.S., Justin Lee, M.P.H., et al., Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation, N Engl J Med 2019; 381:1909-1917
5.https://www.jnjmedicaldevices.com/sites/default/files/2020-07/Burden%20of%20Disease%20Full%20report.pdf
6.Krijthe, Bouwe P., et al. “Projections on the number of individuals with atrial fibrillation in the European Union, from 2000 to 2060.” European heart journal 34.35 (2013): 2746-2751.
7.2017 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. 2016;37:2893–2962.doi:10.1093/eurheartj/ehw210
8.Authors/Task Force Members:, et al. “2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS.” EP Europace 18.11 (2016): 1609-1678.
Volta Medical’s VX1 AI software for use in atrial fibrillation mapping now FDA cleared
Volta Medical’s VX1 AI software for use in atrial fibrillation mapping now FDA cleared
Marseille, December 10, 2020 –Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI (artificial intelligence) software. This is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during atrial fibrillation (AFib) or atrial tachycardia. These annotations help physicians locate heart regions harboring a specific electrogram abnormality, known as spatiotemporal dispersion. This innovative detection and patient-specific localization of abnormal regions may eventually help physicians better decide where they need to intervene to either burn (radiofrequency) or freeze (cryotherapy) faulty electrical pathways.
According to Seth H. Goldbarg, MD, FACC, FHRS, Director of Cardiac Electrophysiology, New York Presbyterian/Queens, Assistant Professor, Weill Cornell Medical College, Flushing, NY, USA, “AFib represents a major challenge in cardiology due to the complexities associated with identification, localization and treatment of the pathological zones that cause and perpetuate this abnormal heart rhythm. The current standard of care does not provide us with a uniform, easy to follow and predictable approach to identify these regions. This has led to heterogenous approaches to treating these patients, with very mixed and often disappointing results. We are excited to be part of the further studies taking place with this AI software, as the VOLTA system may provide a major step forward in the effective approach to ablation of persistent AFib.”
Conventional ablation methods, while useful for treating patients, who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, have so far been less precise in persistent AFib patients than desired. Their results, even if significant in certain cases, remain sub-optimal. Localization and ablation of drivers perpetuating AFib has been at the forefront of cardiovascular disease research but has not led to any radical changes to-date. The Volta mapping system is intuitive, user-friendly and shows promise to potentially reduce inter-operator variability in the analysis of procedural data without lengthening either the diagnostic or therapeutic procedures.
The VX1 system holds enormous promise for offering an easier, faster, more accurate and reliable way to identify zones of interest in patients who suffer from chaotic heart muscle contractions. Developed jointly by top experts in the fields of electrophysiology and digital technologies, VX1 is simple to use. It bears the potential to provide a permanent solution to a chronic health burden with a one-time breakthrough procedure and has the potential to become the gold standard AI solution, for efficient and affordable cardiac ablation procedures. For Jérôme Kalifa, MD and cofounder of Volta Medical “our ultimate goal is to offer an alternative to a lifetime of medication that can have problematic side effects in some patients, while bringing a better quality of life to those who suffer from bothersome daily disease symptoms. This is what is generating increasing enthusiasm around the potential of our solution. The recently obtained FDA clearance is an important milestone for our company and ultimately for patients who suffer from difficult to treat forms of AFib”.
About Volta Medical
Founded by three physicians and a data scientist in 2016 in Marseille, Volta Medical is a HealthTech company developing AI software solutions to assist cardiac electrophysiologists in the operating room. Volta’s overarching goal is to drastically improve cardiac arrythmia 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, assists cardiologists for the real-time identification of specific abnormal electrograms, known as dispersed electrograms.
For more information, visit the company’s website at www.volta-medical.com.
About the VX1 AI software
VX1 consists of a highly innovative AI algorithm that is compatible with most readily available multipolar catheters and technologies currently used in operating rooms or electrophysiology labs. The VX1 software analyzes the patient’s electrograms in real-time to identify specific electrograms known as dispersed electrograms. It also provides a cycle length estimation from electrograms recorded with the mapping and the coronary sinus catheters. The clinical significance of utilizing the VX1 software to help identify areas with intra-cardiac atrial electrograms exhibiting spatiotemporal dispersion for catheter ablation of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations. VX1 is a medical device which is FDA cleared and has a CE mark.
About atrial fibrillation (AFib or AF)
AFib 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. AFib is also a major risk factor for stroke, as stagnant blood in the atrium during AFib may lead to the formation of a clot, that can migrate to the brain. This is why AFib is such an important risk factor for heart failure and stroke and a major reason for loss of quality life.
AFib is expected to reach 12.1 million patients in the US by 2030. Prevalence of arrhythmias increases with age and total annual costs for treatment of AFib in the US were estimated already in 2001 at US$6.65 billion. Evidence suggests a higher prevalence of AFib 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 AFib before, during or after the initial event. AFib increases the likelihood of stroke by four to five times while AFib-induced strokes are generally associated with more severe damage.
Media Contacts
BCW agency
Linda Pavy – Tel: +33 (0)6 07 59 43 95 – Email: linda.pavy@bcw-global.com
Maëly Daviles – Tel: +33 (0)6 13 20 51 02 – Email: maely.daviles@bcw-global.com
Pauline Coudert – Tel +33 (0)6 88 38 46 58 – Email: pauline.coudert@bcw
References
1.https://www.cdc.gov/heartdisease/atrial_fibrillation.htm
2.https://www.uscjournal.com/articles/epidemiology-economic-burden-af
3.Authors/Task Force Members:, et al. “2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS.” EP Europace 18.11 (2016): 1609-1678.
4.https://www.ahajournals.org/doi/10.1161/strokeaha.115.012004
Looking for new talents
Volta Medical brings together a team of top-talent dedicated to make a difference in the field of interventional cardiac electrophysiology.
Volta’s collaborators come from multiple countries and continents.
Our headquarters are located in Marseille. Marseille is in the South of France, on the Mediterranean sea. This creates a unique atmosphere, particularly prone to creativity and collaboration.
At Volta, we are convinced that everyone of us may contribute to improving the lives of patients with cardiac arrhythmias. This is what drives us to come to work every single day. Many of us also enjoy the natural scene and conviviality in Marseille. You may find us celebrating milestones nearby (or on!) the Mediterranean sea.
If you are inspired, feel free to reach out! We would love to review your application.
Science
ABOUT Atrial Fibrillation
The heart beats are generated by the sino-atrial node, a small tissue region in the right atrium. The propagation of impulses to both upper chambers of the heart – i.e the two atria – causes them to contract and move the blood to the lower chambers of the heart, a.k.a the ventricles.
Atrial fibrillation (AF) is the most common heart rhythm disturbance in adults. AF is caused by abnormal electrical impulses forming anywhere in the atria. AF may be recorded on an electrocardiogram (ECG). The beating heart of AF patients is fast and irregular.
Physicians classify AF according to the duration of arrhythmia episodes. Brief episodes correspond to paroxysmal AF. Longer episodes are known as persistent AF.
ABOUT Interventional electrophysiology
Interventional electrophysiology is a surgical specialty. It requires multiple years of experience and consists of conducting intra-cardiac procedures to cure cardiac arrhythmias such as atrial fibrillation.
During an intervention, an electrophysiologist is required to analyze a large amount of information in real-time. First, an accurate visual analysis of up to 30 electrograms is essential. Then, non-electrogram information coming from multiple sources needs additional consideration.
All data allow for seamless progress through the multiple-step procedural workflow.
