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
El Makki Voundy
Full-Stack Developer
Fabienne Pouplier
DPO
Mohsen Shah
US Business Development Manager
Daniel Guerrero
US Clinical Operation Manager
Didier Villevalois
Full-Stack Developer
Philippe Tartaise
Lead Developer
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.
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.
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
Sr. Director, Clinical & QA/RA
Yoann Dutil
Quality Director
Julie Prieur-Garrouste
Quality Engineer
Audrey Balzano
Executive Assistant
Quentin Taburet
Data Scientist
Thomas Boudou
Data Scientist
Camille Schmisser
Clinical Research Engineer
Idriss Lopes Sanches
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.
Anton Vorobev
CFO
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Anton Vorobev
CFO
Anton is an HEC Paris graduate with experience in financial modeling, startup funding and business strategy.
He is co-founder and founder of several start-ups and he led regional operations for a Dutch IT company.
Anton’s business background allows for accelerating Volta’s international growth and helps Volta Medical with refining its financial strategy.
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.
Anthony Appetiti
Head of Sales EU
Rebecca Sircoulomb
Head of product
Investors & Partners
Press releases
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 2020 – 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
Volta Medical raises $2.3M in seed funding to launch a European multicentric study, strengthen its R&D team and prepare the launch of VX1, its intelligent software.
Volta Medical raises $2.3M in seed funding to launch a European multicentric study, strengthen its R&D team and prepare the launch of VX1, its intelligent software.
Marseille (France) October 22, 2018
Volta Medical, a young French med‐tech company that has developed the first Artificial Intelligence (AI) software to guide cardiologists during heart surgeries, announces it has raised € 2.3 million euros in seed funding, including € 2 million from the Pasteur Mutualité Group. The funding round came on the heels of the first tests performed with patients in Marseille (France) and following the hiring of Denis Hansjacob, a prominent figure in the med‐tech industry, as Chief Operating Officer.
The funds raised will be used to implement a European multicentric clinical trial in order to demonstrate the performance of Volta Medical’s AI software during heart surgeries; to expand the company’s R&D team for the development of new products; and to prepare the market launch of AIFib in 2020. AIFib is the first AI software in interventional cardiology capable of guiding surgeons during their procedures, specifically for the treatment of atrial fibrillation (AF).
“Atrial fibrillation, AF, is a severe condition that decreases life expectancy and increases the risk and recurrence of strokes, as well as post‐stroke mortality. Our vision is to offer a solution to this major public health issue, and we thank the Pasteur Mutualité Group for trusting our innovative approach,” said Volta Medical’s four co‐founders, Dr. Julien Seitz, Dr. Clément Bars (Marseille), Dr. Jérôme Kalifa and engineer Théophile Mohr Durdez. “Our ambition, which is ideally aligned with the World Health Organization (WHO) program on heart diseases, is to help improve the treatment of atrial fibrillation – a condition whose prevalence increases as the world population ages – by bringing the artificial intelligence revolution to cardiologists and guiding them during their surgeries.”
“We are delighted to support Volta Medical, our very first investment in a young and promising start‐ up company. Volta Medical and its team hit all the right notes when it comes to our investment policy. They embody the core values of our Group and of the health professionals we serve, namely, the promotion of breakthrough innovation for the benefit of the greater medical community, including by significantly improving key treatments in the field of cardiology. From the company’s young, visionary founders to our mutualist Group, we are also very pleased with the positive approach taken during this operation, marked by a commitment to the evolution of the complex task of practicing medicine,” said Mr. Thierry Lorente, CEO of the Pasteur Mutualité Group.
Volta’s intelligent software, AIFib
AIFib is an AI software developed to guide doctors through the complex medical procedure intended to treat atrial fibrillation, from the detection of electrical foci, which trigger atrial fibrillation, to the surgery itself. Up until now, to identify electrical foci, cardiologists had to maneuver probes inside the heart as a way to identify electrical signals and detect them visually. Such technique is very hard to master, however, and surgeons had to analyze very complex sets of intracardiac electrical signals. Volta Medical had the idea of modeling and automating this technique to make it accessible to a large number of surgeons.
A clinical study is ongoing at Saint Joseph Hospital, in Marseille (France), to test the feasibility of the AIFib software during actual procedures. The initial data obtained on more than 30 patients are very promising and show that doctors’ expertise is either matched or outperformed by the AIFib software. The first results of the study are expected in the spring 2019.
Previous data presented in May 2018, at the annual Heart Rhythm Society Conference, in Boston, already showed that the performance of the software surpassed that of a panel of 28 cardiologists, including that of its creators, as recorded during a conference earlier this year in Marseille.
Atrial fibrillation (AF)
AF manifests itself by an anarchic, rapid and irregular heart rate. These chaotic heartbeats prevent the heart from properly pumping blood. The root cause is an “electrical storm” in the atria disrupting all synchronized activities, so that the mechanical contraction of the atria no longer occurs. The heart loses its strength. The ventricle may momentarily compensate for this loss, but in the long run, the exhaustion of its contractile forces can lead to heart failure. Atrial fibrillation can cause a blood clot in the heart, which may migrate into the brain arteries and cause a stroke.
This is the world’s most common heart arrhythmia and its prevalence increases with age, affecting 1 in 25 adults over 60 and 1 in 10 over 80. There are 7 million patients in the U.S., 11 million in Europe and 750,000 in France (the number of patients is expected to double within the next 30 years). A 55‐ year‐old person has 1 in 4 chances of developing AF during his lifetime (24.8% of men and 22.9% of women). It is therefore a true “epidemic.” AF is a severe disease that decreases life expectancy. AF is responsible for 1 in 6 strokes. The overall prevalence of AF is 5.5% of the population aged 55 and up, and it increases with age (10% at 80 and up). This is a major public health issue whose treatment costs 3,000 euros per year and per patient in France (2.5 billion euros per year in France, with hospitalization accounting for half the costs).
About Volta Medical
Founded in 2016 in the south of France by 3 doctors and one engineer, Volta Medical is a young med‐tech company based in Marseille that develops artificial intelligence (AI) intended for interventional cardiology. The 4 co‐founders are world‐renowned experts in cardiac electrophysiology and intracardiac signal analysis. It took them 10 years to develop a new state‐of‐the‐art medical procedure capable of guiding cardiac surgeons in the treatment of atrial fibrillation. Volta Medical will automate it thanks to the artificial intelligence software AIFib which has been developed by a highly skilled team of engineers and data scientists.
For more information: https://www.volta‐medical.com
About the Pasteur Mutualité Group
As a 160‐year‐old leading mutual insurance group managed by and intended to healthcare professionals, the Pasteur Mutualité Group is committed to helping its members, from the beginning of their studies, to provide them with solutions catered to the needs of their professional and private lives. Our DNA is marked by strong values of mutual assistance, respect and fairness. The spirit of our Group and its members is also the foundation of our strong Corporate Social Responsibility (CSR) investment policy. The Group places innovation at the heart of its development project. With more than 138,000 members, the Pasteur Mutualité Group is the preferred partner of healthcare professionals.
For more information: www.gpm.fr
Follow the Pasteur Mutualité Group on Twitter: @gpm_en
Heart diseases in numbers
French figures (Sources: Inserm)
✔ In France, heart diseases are responsible for 180,000 deaths every year
✔ Coronary artery diseases (including myocardial infarctions), strokes, and heart failures (HF) account for 27%, 25%, and 23% of all cardiovascular deaths, respectively. That does not include the sequelae and handicaps caused by heart diseases.
✔ In France, 120,000 people are treated each year for a myocardial infarction, 130,000 people for a stroke and about as much for HF.
World figures (Sources: WHO)
✔ Coronary artery diseases (ischemic diseases) and strokes are the leading cause of death worldwide. They accounted for a total of 15 million deaths in 2015.
✔ They have been the leading causes of death in the world for the past 15 years.
Press contacts
ALIZE RP
Caroline Carmagnol and Najette Chaib
+33 (0)6 64 18 99 59 / voltamedical@alizerp.com
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.
Chef de Projet H/F
Marseille, France
Chef de Projet H/F
Qui sommes nous ?
Volta Medical est une start-up marseillaise présente à l’international. Notre but est de fournir aux hôpitaux une gamme de logiciels intelligents et innovants qui guident les cardiologues pendant les interventions chirurgicales de type ablation au bloc opératoire. Volta Medical a été créée par un data scientist et des cardiologues renommés. Notre produit est l’un des premiers logiciels basés sur l’intelligence artificielle à servir lors d’interventions chirurgicales. Aujourd’hui, l’équipe compte plus d’une trentaine de membres.
Volta Medical, c’est un savant mélange d’exigence, d’agilité et de proactivité, le tout dans un environnement multiculturel.
Nous nous sommes lancés dans cette aventure il y a plus de quatre ans et amorçons une phase de croissance rapide !
Contexte
Dans le cadre d’une campagne de collecte et d’annotation de données, nous recherchons un Chef de Projet expérimenté dans le but de coordonner l’ensemble des parties prenantes.
Cette collecte de données s’effectuera à l’aide de notre produit The Line, outil inédit et innovant.
Mission
– Définir les données d’entrée et le planning initial du projet,
– Intégrer les aspects juridiques et réglementaires du projet,
– Organiser des réunions régulières avec l’ensemble des parties prenantes afin d’assurer la mise en œuvre de la collecte et de l’annotation des données et de mettre à jour le plan opérationnel,
– Faciliter la communication des différentes parties prenantes (juridique opérationnelle, produit, scientifique et clinique) du projet en centralisant les informations,
– Faire un reporting régulier de l’avancement du projet auprès de la Direction.
Expérience requise
– Au moins 5 ans d’expérience en tant que Chef de Projet dans le domaine du numérique,
– Résolution de problématiques de déploiement logiciel,
– Coordination de projets pluridisciplinaires intégrant des enjeux réglementaires, juridiques, techniques et opérationnels,
Compétences
– pluri-disciplinarité,
– gestion de projet
– grandes capacités organisationnelles et de coordination,
– maitrise des outils de gestion de projet (MS project),
– Anglais,
– Microsoft Office.
Nice to have
– Maîtrise du RGPD,
– Avoir été confronté à des problématiques de collecte de données de santé,
– Expérience dans les dispositifs médicaux,
– Sensibilisé à la méthode agile,
– Certification “PMP” du PMI project management professional.
Savoir-être
– Proactivité,
– Bon communiquant,
– Méticuleux,
– Esprit de leader et de chef d’orchestre.
Conditions et process de recrutement
Le poste est en CDI, statut cadre. Marseille 6 ème. Rémunération en fonction du profil. Cette annonce vous donne envie ? Alors n’hésitez pas à postuler ! Nous nous chargerons d’évaluer votre candidature dans les plus brefs délais. Nous vous invitons à envoyer votre CV : hr@volta-medical.com
Responsable Assurance Qualité H/F
Marseille, France
Responsable Assurance Qualité H/F
Qui sommes nous?
Volta Medical est une start-up marseillaise présente à l’international. Notre but est de fournir aux hôpitaux une gamme de logiciels intelligents et innovants qui guident les cardiologues pendant les interventions d’électrophysiologie cardiaque de type ablation. Volta Medical a été créée par un data scientist et des cardiologues renommés. Notre premier produit, marqué CE et homologué 510(k) par la FDA, est l’un des premiers logiciels basés sur l’intelligence artificielle à servir au bloc opératoire. Aujourd’hui, l’équipe compte plus d’une trentaine de membres avec une filiale aux Etats-Unis.
Volta Medical, c’est un savant mélange d’exigence, d’agilité et de proactivité, le tout dans un environnement multiculturel.
Nous nous sommes lancés dans cette aventure il y a plus de quatre ans et amorçons une phase de croissance rapide ! Nous venons d’ailleurs d’opérer à une levée de fond de $27M.
Pour en savoir plus concernant nos actualités, rendez-vous sur : https://www.volta-medical.com.
Missions
Au sein du département Clinique, Qualité et Affaires Réglementaires, le/la Responsable Assurance Qualité aura pour mission de :
• Accompagner l’ensemble de la société dans une démarche qualité,
• Superviser la gestion et amélioration du système de management de la qualité pour assurer la conformité aux référentiels applicables,
• Maintenir les tableaux de bord des KPI et préparer et animer les revues de direction,
• Gérer le traitement des réclamations clients,
• Gérer la gestion des non-conformités,
• Suivre et mettre en place les actions préventives et correctives,
• Intervenir sur les développements des produits et procédés et organisation de la production,
• Valider la libération des produits,
• Participer à la rédaction de la documentation technique des produits,
• Gérer les audits internes et externes,
• Superviser les achats et la gestion des sous-traitants,
• Manager une équipe de 2 personnes.
Profil recherché
Vous êtes le candidat idéal si :
• Vous êtes diplômé d’une formation supérieure de type Ecole d’Ingénieur ou Master en Affaires Réglementaires/Assurance Qualité DM,
• Vous bénéficiez d’une expérience de 7 ans minimum en Assurance Qualité dans une entreprise de dispositifs médicaux,
• Vous parlez couramment anglais (échanges quotidiens à l’écrit et à l’oral),
• Vous maîtrisez parfaitement la norme ISO 13485, le 21 CFR 820, le règlement 2017/745/UE,
• Vous avez une certification auditeur et/ou une expérience significative en audits internes/externes,
• Vous avez une expérience en gestion de projets transversaux,
• Vous avez une expérience en management d’équipe,
• Vous savez prioriser et gérer plusieurs tâches et responsabilités,
• Vous avez des compétences en matière de communication et de pédagogie pour promouvoir la qualité dans l’ensemble de l’entreprise.
Volta Medical est faite pour vous si vous appréciez travailler en équipe dans des environnements en mouvement, au sein duquel vous saurez faire preuve de dynamisme, d’enthousiasme et de prise d’initiative.
Conditions et processus de recrutement
Le poste est en CDI. Le poste est basé à Marseille 6ème avec possibilité de télétravail occasionnel (2 jours par semaine maximum). Rémunération en fonction du profil.
Cette annonce vous donne envie ? Alors n’hésitez pas à postuler !
Notre HR Manager se chargera d’évaluer votre candidature dans les plus brefs délais. Nous vous invitons à lui envoyer votre CV : hr@volta-medical.com
Si votre CV convient, elle vous contactera pour un premier échange téléphonique. Puis, nous vous rencontrerons lors d’un entretien physique ou visio.
Spécialiste Affaires Réglementaires H/F
Marseille, France
Spécialiste Affaires Réglementaires H/F
Qui sommes nous?
Volta Medical est une start-up marseillaise présente à l’international. Notre but est de fournir aux hôpitaux une gamme de logiciels intelligents et innovants qui guident les cardiologues pendant les interventions d’électrophysiologie cardiaque de type ablation. Volta Medical a été créée par un data scientist et des cardiologues renommés. Notre premier produit, marqué CE et homologué 510(k) par la FDA, est l’un des premiers logiciels basés sur l’intelligence artificielle à servir au bloc opératoire. Aujourd’hui, l’équipe compte plus d’une trentaine de membres avec une filiale aux Etats-Unis.
Volta Medical, c’est un savant mélange d’exigence, d’agilité et de proactivité, le tout dans un environnement multiculturel.
Nous nous sommes lancés dans cette aventure il y a plus de quatre ans et amorçons une phase de croissance rapide ! Nous venons d’ailleurs d’opérer à une levée de fond de $27M.
Pour en savoir plus concernant nos actualités, rendez-vous sur : https://www.volta-medical.com.
Missions
Au sein du département Clinique, Qualité et Affaires Réglementaires, le/la Spécialiste Affaires Réglementaires aura pour mission de :
➔ Participer à la stratégie de mise sur le marché des nouveaux produits,
➔ Coordonner la constitution et mise à jour des dossiers techniques en conformité avec les exigences réglementaires applicables et en étroite collaboration avec les différents services,
➔ Participer aux design changes et gérer leurs impacts réglementaires,
➔ Gérer l’enregistrement des produits et des opérateurs économiques (nouvelles demandes, modifications, renouvellements, maintiens) en Europe et aux US,
➔ Gérer l’étiquetage des produits (exigences réglementaires Europe/US et relation fournisseur),
➔ Gérer la veille réglementaire et les analyses d’écart par rapport aux exigences réglementaires applicables,
➔ Vérifier la conformité des manuels d’utilisation et des documents promotionnels,
➔ Participer aux audits internes et externes,
Profil recherché
Vous êtes le candidat idéal si :
– Vous êtes diplômé d’une formation supérieure de type Ecole d’Ingénieur ou Master en Affaires Réglementaires,
– Vous bénéficiez d’une expérience de 3 ans minimum en Affaires Réglementaires dans les dispositifs médicaux actifs,
– Vous parlez couramment anglais (échanges quotidiens à l’écrit et à l’oral),
– Vous maitrisez le règlement 2017/745/UE,
– Vous bénéficiez de connaissances pratiques des normes associées aux dispositifs médicaux (ISO 13485, IEC 60601, IEC 62304, ISO 14971, IEC 62366, ISO 15223, EN 1041, etc.)
– Vous avez une expérience réussie dans la mise sur le marché d’un dispositif médical et/ou dans la gestion de projets R & D.
Des connaissances sur la réglementation américaine (de novo, 510(k), PMA, IDE) et leur implémentation concrète seraient un plus.
Volta Medical est faite pour vous si vous appréciez travailler dans des environnements en mouvement, au sein duquel vous saurez faire preuve de dynamisme, d’enthousiasme et de prise d’initiative.
Conditions et processus de recrutement
Le poste est en CDI (création de poste). Le poste est basé à Marseille 6ème avec possibilité de télétravail occasionnel. Rémunération en fonction du profil.
Cette annonce vous donne envie ? Alors n’hésitez pas à postuler !
Notre HR Manager se chargera d’évaluer votre candidature dans les plus brefs délais. Nous vous invitons à lui envoyer votre CV : hr@volta-medical.com
Si votre CV convient, elle vous contactera pour un premier échange téléphonique. Puis, nous vous rencontrerons lors d’un entretien physique ou visio.
Software Test Engineer, H/F, Marseille
Marseille, France
Software Test Engineer, H/F, Marseille
Who are we ?
Volta Medical is an AI medtech startup. Volta has developed the first AI software to guide physicians in atrial fibrillation (AF) treatment during a curative intervention called ablation. With 11 million patients in the EU alone (14-17 million in 2030) and 33 million patients worldwide, AF is the most common arrhythmia (irregular heart rhythm) in adults and ablation is currently one of the most advanced treatment options.
After 15+ years of research, Volta Medical has developed a product using a data-driven approach for optimal real-time identification of dispersion zones during atrial fibrillation ablation. This solution is built on artificial intelligence (AI, deep and machine learning) approaches to gain insight into innovative therapies for AF.
Volta is based in Marseille and has international presence in the USA. Our mission is to provide a range of intelligent and innovative softwares that will guide the cardiologist during surgical procedures in the operating room. We have recently raised our series A round and the team now consists of more than 30 collaborators with a branch in the United States. We embarked on this adventure more than four years ago and are entering another phase of rapid growth.
At Volta Medical we believe in maintaining high standards, agility and proactivity in our work. We have a multicultural team, embracing diversity and gender balance at the workplace.
Job brief
The candidate will collaborate with regulatory and development teams for a continuous improvement of software quality.
Under the supervision of the CTO, the test software engineer will work closely with the product manager and developers during the whole product life cycle to elaborate the test strategy and execute it.
He/she will ensure requirements and design are tested and produce required regulated artifacts during verification and validation phases. He/ she will be responsible of the problem report procedure that ensure defect management.
Responsibilities
You will work with a the R&D team composed of data scientists and developers using the Agile Methodology. In this context, you will:
➔ Create test strategy and plan to ensure verification of our product,
➔ Create manual test cases and auto test for integration/ verification testing according to procedure
➔ Define stories/ epics acceptance criteria in collaboration with product owner and developpers
➔ Review software requirements and provide input to ensure they are testable
➔ Set up test bench/ environment,
➔ Test execution and campaign planning, defect management (problem report),
➔ Perform smoke test and regression testing,
➔ Set up test management software to ensure traceability and coverage,
➔ Support validation process and usability testing in collaboration with product team
➔ Configuration management
Required Experience
– 3-5 years’ experience covering the entire software lifecycle (requirements definition through validation) as a software test engineer in the Medical Device industry in a team environment.
– Knowledge of medical device software standards: IEC 62304 and ISO 13485 QMS
– Msc. in Computer Science or similar engineering discipline including Software Engineering or Biomedical Engineering is required.
Valued Experience
– Functional, usability and cybersecurity testing,
– Experienced with risk analysis
– ISTQB
– Experience with agile development.
– Experienced working with test management software (Jira, Xray,Testrail ..)
Soft skills
– Problem-solving aptitude
– Good communication skills
– Attention to details
– Strong organizational capabilities required.
– Ability to communicate and write documents in english
Recruitment process
The position is on a full-time CDI, “cadre” status, based in Marseille 6th.
Does this sound exciting to you ? Then do not hesitate to apply!
Loren Siry will assess your application as soon as possible.
Do not hesitate to send her your resume/CV: hr@volta-medical.com
Data Scientist H/F
Marseille, France
Data Scientist H/F
Who are we ?
Volta Medical is an AI MedTech startup. We have developed the first AI software to assist
physicians in atrial fibrillation treatment during a curative intervention called ablation. With 11
million patients in the EU alone (14-17 million in 2030) and 33 million patients worldwide, AF is the
most common arrhythmia (irregular heart rhythm) in adults and ablation is currently one of the
most advanced treatment options.
Based on 15+ years of research, Volta Medical has developed a product using a data-driven
approach for optimal real-time identification of regions of interest during atrial fibrillation ablation.
This solution builds on artificial intelligence (AI, deep and machine learning) approaches to gain
insight into innovative therapies for AF.
Volta is based in Marseille, France, and has international presence in the USA. Our mission is to
provide a range of intelligent and innovative software that will guide the cardiologist during
surgical procedures in the operating room. We have recently raised our series A round and the
team now has more than 30 collaborators with a branch in the United States. We embarked on this
adventure more than four years ago and are entering another phase of rapid growth.
At Volta Medical we believe in maintaining high standards, agility and proactivity in our work. We
have an enthusiastic multicultural team, embracing diversity and gender balance at the
workplace.
Job brief
We are looking for a Data scientist to be a part of our R&D team. Solid technical background and
interest in AI for health applications are essential in this role.
Responsibilities
You will be part of a technical team of around 12 people (8 Developers and 4 Data Scientists). In
this context, you will:
➔ Build state of the art machine learning algorithms to be used in the EP Lab
➔ Participate in the effort to develop better data collecting tools suited to the constraints of
the health domain.
➔ Participate in the production of necessary regulatory documents for the clearance /
approval of the developed softwares.
➔ Produce code of high quality (coding guidelines, unit tests, etc.)
➔ Communicate technology strategy to partners and investors
➔ Participate in scientific congresses
Required Profile
– Graduate from a master’s / engineering school (BAC + 5), in mathematics, physics, data
science or statistics,
– At least 1 year of experience in Machine Learning R&D projects
Managerial, strategic and soft skills
– Problem-solving aptitude
– Ability to conduct technological analyses and research
– Excellent communication skills
– Excellent organizational and time-management skills
– Attention to details.
– Interested in the recent developments of AI / ML research
Technical experience
– Very good academic level in machine learning (mathematical and algorithmic background,
good practices in ML, Deep learning, Classical machine learning algorithms, Signal
processing, etc …)
– Computer Science (Complexity calculation, parallel programming)
– Python (PyTorch, Tensorboard, Pandas, numpy, asyncio, Pytest, scikit-learn, XGBoost, etc…)
– GIT
– Docker
– Database
– Linux
– Very good level in English
These technologies are not required but would be appreciated:
– PostgreSQL
– Advanced knowledge in computer science (Dynamic programming, socket communication
protocols, etc …)
– Code optimization in python (Numba / Cython)
– Lower level computer language knowledge (C, Assembly, etc…)
– Have participated in the publication of a scientific article
Recruitment process
The position is on a full-time CDI, “cadre” status, based in Marseille 6th.
Does this sound exciting? Don’t hesitate to apply!
Do not hesitate to send your CV to hr@volta-medical.com If your CV is
accepted, our HR will contact you for a first phone conversation.
Candidates who will unfortunately not be selected will receive an email.
Ingénieur d’Application Electrophysiologie H/F
Marseille, FR
Ingénieur d’Application Electrophysiologie H/F
Qui sommes-nous ?
Volta Medical est une start-up marseillaise présente à l’international. Notre but est de fournir aux hôpitaux une
gamme de logiciels intelligents et innovants qui guident les cardiologues pendant les interventions chirurgicales
de type ablation au bloc opératoire. Volta Medical a été créée par un data scientist et des cardiologues renommés.
Notre produit est l’un des premiers logiciels basés sur l’intelligence artificielle à servir lors d’interventions
chirurgicales. Aujourd’hui, l’équipe compte plus d’une vingtaine de membres.
Volta Medical, c’est un savant mélange d’exigence, d’agilité et de proactivité, le tout dans un environnement
multiculturel.
Nous nous sommes lancés dans cette aventure il y a plus de quatre ans et amorçons une phase de croissance rapide !
Voici l’un des derniers articles qui nous a été consacré: https://www.lesechos.fr/pme-regions/innovateurs/voltamedical-obtient-le-marquage-ce-pour-son-ia-en-cardiologie-1181673
Mission:
En collaboration direct avec le COO et le Head of Business Development, l’Ingénieur Application sera en charge
de :
• Déployer et installer nos solutions chez le client,
• Être en charge du support des applications lors des opérations auprès des médecins
(notamment lors des déploiements de nos études cliniques,
• Former les médecins et les équipes sur place à l’utilisation de nos solutions,
• Être l’interlocuteur privilégié des clients,
• Jouer un rôle central dans la relation et la fidélisation client. Vous êtes l’ambassadeur de nos
produits.
Le profil recherché :
Vous êtes le candidat idéal si :
• Vous bénéficiez d’une première expérience réussie sur un poste similaire (au minima une période de stage),
• Vous êtes diplômé d’un Bac + 5 dans le domaine biomédical,
• Vous parlez anglais couramment.
Volta Medical est fait pour vous si vous appréciez travailler dans des environnements en mouvement, au sein
duquel vous saurez faire preuve de polyvalence, autonomie et de prise d’initiative.
Conditions et process de recrutement :
Le poste est en CDI. Les missions sont réalisées en télétravail avec des déplacements fréquents sur la France, les
pays frontaliers ainsi que sur notre siège à Marseille. Rémunération en fonction du profil.
Cette annonce vous donne envie ? Alors n’hésitez pas à postuler !
Loren Siry se chargera d’évaluer votre candidature dans les plus brefs délais. Nous vous invitons à lui envoyer votre
CV : hr@volta-medical.com
Si votre CV convient, elle vous contactera pour un premier échange téléphonique. Puis, nous vous rencontrerons
lors d’un entretien physique ou visio. Pour les candidats qui ne seront malheureusement pas retenu, un mail vous
sera transmis
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.
