Episurf Medical announces the initiation of an investigator-initiated European multicentre study with 5 years’ follow-up of 50 Episealer® Knee patients. The study is a continuation of the European multicentre study, from which 2 years’ follow-up results were published in September 2020 .
The interim study from 2020 concluded that the results indicate that there is a definitive place for the Episealer® device in the management of a focal chondral or osteochondral defect affecting the distal femur. The study sponsor, investigator Associate Professor Tim Spalding, University Hospitals Coventry and Warwickshire NHS Trust, UK, will now perform the 5 years’ follow-up together with surgeons from 8 additional clinics in 6 European countries. Preliminary results from the follow-up are expected during the fourth quarter of 2021, while full results are expected in early 2022.
“This study can be performed thanks to the study group's engagement and persistent follow-up of their patients, and we appreciate the initiative taken by Mr Tim Spalding. There has previously been a focus on 2 years’ data for the Episealer® patients. We are happy to now be in a position to get results from a large group of patients that have had their implants for 5 years. Recent publications with strong 2 years’ results have been very useful in Episurf’s dialog with healthcare providers, customers, and authorities in our markets. We are confident that the 5 years’ results will provide even stronger evidence in support of the Episealer®, showing that the technology is reliable over time” says Pål Ryfors, CEO Episurf Medical.
Source: Episurf Medical