Postmarket surveillance survival data for Episurf Medical's Episealer® Knee implant show a cumulative survival rate of >96% over seven years. The study, Patient-specific implants for focal cartilage lesions in the knee: implant survivorship analysis up to seven years post-implantation, focused on survival data for 682 Episealer knee implants implanted between 2012 and 2020.
The data was published in the journal, Surgical Technology International.
"This publication on the implant survival status of the Episealer® device merits some significance. First, this is a report on all implants so far delivered at the date of the report, i.e. these results are representative for, not the few specially interested clinics, but for an entire cohort of surgeons. Secondly, the number of revisions is conspicuously low, on par with the best TKA-designs in the Swedish Knee Registry. Finally, and perhaps most importantly, all implant revisions have so far occurred before 30 months post-op. This means that the inappropriate cases - they exist in all types of surgery - fall out early. Our hypothesis is, that having passed 30 months, these implants may last for a very long time," said Pål Ryfors, CEO Episurf Medical.
This is the fifth peer-reviewed clinical article on the Episealer knee implant accepted for publication, of which three have been accepted in 2020. Since before, there are five pre-clinical papers published.