Prosidyan received two CE Marks for FIBERGRAFT BG Putty, FIBERGRAFT BG Putty GPS and FIBERGRAFT BG Morsels.
FIBERGRAFT is an ultraporous synthetic bone graft substitute made from proprietary nano- and micro-sized bioactive glass fibers to provide direct connectivity, high surface area and optimized resorption rates.
To support the CE Mark application, Prosidyan collected and analyzed retrospective data from 155 patients at four U.S. centers. Standard of care post-operative imaging was used to assess fusion and provide real-world evidence of successful outcomes with FIBERGRAFT.
“As a Company, we are excited to achieve this milestone in expanding our international sales footprint. Based on our customer experience, we are confident in the clinical performance of our FIBERGRAFT technology, and continue to focus on evidence generation and research and development. Surgeons want their patients to heal faster with fewer complications and that motivates us to be a trusted partner in delivering such outcomes,” said Charanpreet Bagga, CEO and Co-Founder.
Considering the EU’s Medical Device Directive’s (93/42/EEC MDD) requirements, “the bar was high and FIBERGRAFT demonstrated fusion rates over 90% in a diverse and heterogenous patient population and across multiple sites and multiple levels of fusion. Due to the strength and diversity of our data sets, we’re pleased to have been granted broad indications for the FIBERGRAFT BG Putty and FIBERGRAFT BG Morsels product portfolios for fusion procedures in the lumbar and anterior cervical spine,” said Bagga.