Clamart, France,15 October 2021 - MicroPort CRM, a pioneering company in Cardiac Rhythm Management (CRM) headquartered in France with global operations, today announced the completion of patient recruitment in the Apollo clinical study aimed at meeting the primary objectives. Apollo is a pre-market study assessing the safety and efficacy of the Invicta defibrillation lead. The main objectives are evaluated on the first 157 patients followed for 3 months. Since the study began in June 2021, 33 European centers have been involved.
Invicta is a 7F diameter lead equipped with a screw fixation and one or two defibrillation coils. The lead is designed to be 1.5 and 3 Tesla MRI conditional when implanted with MicroPort CRM Ulys and Edis Implantable Cardiac Defibrillators (ICD), as well as Gali devices for Cardiac Resynchronization Therapy (CRT- D).
Principal investigator of the Apollo study, Dr Pedro Marques of Santa Maria Hospital, Lisbon, commented, "I am very satisfied with the way this study is being conducted. The first 157 inclusions have been reached more than a month ahead of the initial schedule, made possible thanks to the very good performance of the Invicta lead during the implantation procedure, as well as the great contribution of the centers participating in the study. I would like to thank all the investigators for their involvement".
Benoît Clinchamps, President of MicroPort CRM, commented, “The Apollo Study is a key milestone for MicroPort CRM, which we will use as a cornerstone to build a new line of implantable defibrillation systems, including both devices and leads, 1.5 and 3 Tesla MRI conditional and equipped with the advanced features that characterize our products, including an outstanding longevity. Thanks to our technology and the strengthening of our commercial offering, we have a good growth perspective ahead of us, with Invicta expected to be marketed for the first time in Europe in 2022, followed by Japan, after obtaining regulatory certifications”.
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), with world headquarters in Clamart, near Paris, France. Through its long-standing expertise in CRM, MicroPort® CRM develops, manufactures and markets 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, Shanghai, China, and in Santo Domingo, Dominican Republic.
For more information, please refer to www.microport.com