MicroPort® CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM), whose world headquarters are in Clamart, near Paris, France. Through our long-standing expertise in CRM, MicroPort CRM develops, manufactures and market around the world cardiac pacemakers, implantable cardiac defibrillators, cardiac resynchronization systems and ECG diagnostic solutions for the management of cardiac rhythm disorders and heart failure. Our state-of-the-art products are manufactured in Clamart, France, Saluggia, Italy, and in Santo Domingo, Dominican Republic.
Previously known as SORIN CRM, MicroPort CRM has built its reputation in MedTech through innovations, especially in the field of Cardiac Resynchronization Therapy (CRT). In 2008, it introduced a cardiac contractility sensor, SonR, to automatically and regularly optimize resynchronization parameters.
The company employs more than 1,000 employees worldwide and has the European’s largest manufacturing clean room for medical devices in Clamart, France.
MicroPort CRM is the coordinator of the Axone project. In this project, MicroPort CRM is responsible for the manufacturing and system validation to fulfil regulatory and quality requirements. MicroPort CRM will be responsible for the worldwide commercialization and dissemination of Axone after obtaining the required regulatory approvals.
Heraeus Medical Components – a Global Business Unit of Heraeus Group – is a market-leading medical device outsourcing partner to medical device OEMs. The company provides expertise in materials science, leading-edge manufacturing technologies and supply chain excellence to support customers in the development and production of components, assemblies and finished devices. With a global production footprint and over 1,800 employees worldwide, Heraeus Medical Components is committed to helping their customers bring better medical devices to market. In the Axone project, Heraeus is responsible for material transformation, component manufacturing and process validation, in order to provide the subcomponents essential to the construction of the Axone lead to MicroPort CRM.
Heraeus, the technology group headquartered in Hanau, Germany, is a leading international family-owned portfolio company. The company’s roots go back to a family pharmacy started in 1660. Today, the Heraeus group includes businesses in the environmental, electronics, health and industrial applications sectors. Customers benefit from innovative technologies and solutions based on broad materials expertise and technological leadership.
Maastricht University (Universiteit Maastricht) was founded in 1976 and has 5 faculties including the faculty of Health, Medicine and Life Sciences (FHML). The Cardiovascular Research Institute Maastricht (CARIM) is part of FHML and is embedded within the Maastricht University Medical Center+ (MUMC+). With an annual budget of more than 20 M€, CARIM is one of the largest cardiovascular research institutes in Europe, producing more than 500 scientific articles and approximately 40 PhD dissertations per year.
The university has acquired an expertise in the field of heart failure through the development of heart failure animal models and preclinical trials of various CRT therapies. Therefore, in the Axone project, Maastricht University is responsible for the pre-clinical evaluation of the finished device, under GLP conditions to demonstrate safety and effectiveness of the product before human clinical use.
Prof. Frits Prinzen is a professor of Physiology and the leader of the theme “electro-mechanics of the heart” within CARIM. His main research topic is regional cardiac mechanics and long-term structural and functional adaptations to various conditions, with emphasis on asynchronous electrical activation and cardiac resynchronisation. With this background Prof. Frits Prinzen is a world expert on pacing therapies, both for bradycardia and for heart failure (cardiac resynchronisation therapy, CRT)
Rouen University Hospital (Centre Hospitalier Universitaire de Rouen) is a primary healthcare facility, dedicated to 3 main missions: care, training and research. Each year, more than 30,000 patients choose this facility for surgical operations and 420,000 patients are received for medical visits. Over the last decades, the Cardiology department of Rouen University Hospital has been at the edge of innovation with the development of transcatheter aortic valve implantation (TAVI). In the field of cardiac arrhythmia, the department has been the first to treat atrial flutter using percutaneous catheter and fulguration energy.
More recently, clinical research has been focused on the relevance of multisite pacing in patients with heart failure and mechanical and electrical dyssynchrony. The Axone project is therefore a natural continuation of the current institutional work of Rouen University Hospital, which is responsible for the clinical evaluation of the product in acute and chronic phases.
Prof. Frédéric Anselme is a professor of cardiology at Rouen University Hospital and the principal investigator for the ASTRAL study. He was at the origin of the concept of passing a microlead through venous collaterals to multiply the sites of ventricular stimulation for CRT patients and was directly involved in the design phases and clinical evaluation of Axone. His areas of expertise include catheter ablation of cardiac arrhythmias, and cardiac resynchronization therapy for heart failure patients.