Elutia Launches FDA-Cleared EluPro™ for Infection Prevention in Implantable Devices

Elutia Inc., a leader in drug-eluting biomatrix technologies, has officially launched EluPro™, the first FDA-cleared antibiotic-eluting biomatrix designed for use with cardiac implantable electronic devices (CIEDs) and neurostimulators, in the U.S. EluPro represents a groundbreaking advancement by addressing two critical challenges for patients: infection prevention and enhanced healing of the surgical pocket. Featuring rifampin and minocycline embedded within a regenerative biomatrix, EluPro mitigates complications such as infection, migration, and erosion while promoting healthy tissue regeneration. The product is compatible with all major CIED and neurostimulation device brands, meeting a significant need in a U.S. market valued at $600 million annually.

The nationwide rollout follows a successful pilot program that demonstrated strong physician adoption and positive patient outcomes at over 70 institutions. During this phase, Elutia navigated approvals with 136 hospital value analysis committees (VACs) and formed relationships with major group purchasing organizations, including Premier and S3P. Dr. Randy Mills, CEO of Elutia, highlighted the robust demand for EluPro, citing a 50% increase in orders at VAC-approved institutions. "This launch marks a significant advance in care for patients with implantable devices," said Mills. "Our team’s efforts have laid the foundation for EluPro to redefine standards in infection prevention and surgical healing."