Clamart, France, February 26, 2021 - MicroPort® CRM, a pioneer in the field of Cardiac Rhythm Management (CRM) has announced its partnership with the French start-up bepatientTM to launch a clinical study on heart failure (HF) patients using remote monitoring.
This observational e-cohort study, to be conducted in France and sponsored by bepatientTM, is designed to better describe how heart failure care is delivered in real life, and to collect data that will help inform the development of new devices and applications to improve patient outcomes.
The study will follow 428 patients with HF for at least one year, who are implanted with MicroPort® CRM implantable defibrillators and equipped with the bepatientTM “.cardioHFTM” remote monitoring solution. This clinical partnership will allow data from the implanted device to be integrated with the patient's weight, using a connected scale, and symptoms, which are collected via the “.cardioHFTM” application.
“Collecting real world patient data is key to our clinical research and the use of connected medical devices opens up new possibilities,” said Amel Amblard, Vice President of Clinical Affairs at MicroPort® CRM. "The partnership with bepatientTM gives us the opportunity to enrich the data collected through our implanted devices and to make a leap forward in the care of patients with the ultimate objective of predicting cardiac decompensation events.”
The prevalence of heart failure is very high worldwide, between 1 and 2% in developed countries. In France, it is estimated that one million people are affected by this disease, and that approximately 160,000 per year are hospitalized. One of the major challenges is to reduce hospitalizations, which better patient monitoring should allow.
“We are proud to partner with MicroPort® CRM, which will work with us to promote the study to centers in France and accelerate its deployment. Beyond improving the care pathway for heart failure patients thanks to data intelligence, this study is a first step towards the sustainability of our business model, made possible by new reimbursement schemes in France and in Europe. It also strengthens bepatientTM's positioning in the highly innovative segment of Digital Therapeutics”, said Frédéric Durand Salmon, CEO of bepatientTM.
The “.cardioHFTM” solution is a CE marked medical device fully reimbursed by the French authorities under the ETAPES1 program in France. One of the objectives of the ETAPES program is to promote remote monitoring of Heart Failure patients to avoid decompensation events and reduce hospitalizations. Patients enrolled in the study will be required to meet the ETAPES criteria.
About MicroPort® CRM
MicroPort® CRM is a pioneering company in the field of Cardiac Rhythm Management (CRM), and a subsidiary of MicroPort Scientific Corporation (stock code: 00853.HK), whose world headquarters are in Clamart, near Paris, France. Through our long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets 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.
For more information, please refer to www.microport.com
bepatientTM is a French start-up that has been developing since 2011 a comprehensive and modular core platform, enabling patients to be connected at home to Healthcare Professionals and to generate value-added Real-World Evidence (RWE) data. The bepatientTM portfolio of solutions is structured around two activities: Clinical Research digitalization via direct-to-patient virtual trials technologies (ePRO, eCOA, eConsent, integration of connected devices, eCRF, etc.) and Digital Therapeutics: evidence-based Companion Apps integrating symptom checking, management of treatment adherence, remote monitoring, eLearning ...
bepatientTM's activities are mainly concentrated in Europe, with a wide range of therapeutic areas such as cardiology, inflammatory diseases, oncology, metabolic diseases and chronic pain.
Joël Courville – MicroPort CRM
VP Strategy and Corporate Affairs
1 ETAPES (Expérimentation de Télémédecine pour l'Amélioration des Parcours En Santé) is a national program in France to experiment remote monitoring in practice for several pathologies including heart failure.